Trial Outcomes & Findings for Lifestyle Modification and Liraglutide (NCT NCT02911818)
NCT ID: NCT02911818
Last Updated: 2019-05-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
Randomization and 52 weeks
Results posted on
2019-05-07
Participant Flow
This trial enrolled 150 participants for the original 52-week study. The 12-week extension study randomized 45 participants from the 100 eligible from the original 52-week trial who were originally in either the CMS-Liraglutide or Multi-Component groups. Eligible participants for the 12-week extension had to complete 1 year on liraglutide.
Participant milestones
| Measure |
CMS-Alone
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
12-Week Extension Study: Phentermine Group
After the 1-year trial, half the participants who elect to join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Phentermine 15 MG
|
12-Week Extension Study: Placebo Group
After the 1-year trial, half the participants who elect to join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Placebo Oral Tablet
|
|---|---|---|---|---|---|
|
52 Week Study
STARTED
|
50
|
50
|
50
|
0
|
0
|
|
52 Week Study
COMPLETED
|
46
|
45
|
46
|
0
|
0
|
|
52 Week Study
NOT COMPLETED
|
4
|
5
|
4
|
0
|
0
|
|
12 Week Extension Study
STARTED
|
0
|
0
|
0
|
22
|
23
|
|
12 Week Extension Study
COMPLETED
|
0
|
0
|
0
|
22
|
22
|
|
12 Week Extension Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lifestyle Modification and Liraglutide
Baseline characteristics by cohort
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling, on the visit schedule currently recommended by the CMS.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 11.0 • n=39 Participants
|
45.2 years
STANDARD_DEVIATION 12.3 • n=41 Participants
|
48.0 years
STANDARD_DEVIATION 11.9 • n=35 Participants
|
47.6 years
STANDARD_DEVIATION 11.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
119 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
31 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
67 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
81 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Percent Change in Baseline Weight
|
-6.1 percent change
Standard Error 1.3
|
-11.5 percent change
Standard Error 1.3
|
-11.8 percent change
Standard Error 1.3
|
PRIMARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=22 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=23 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Primary Outcome: Percent Change in Re-randomization Weight
|
-1.6 percent change
Standard Error 0.6
|
-0.1 percent change
Standard Error 0.5
|
—
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure
|
-14.1 mm Hg
Standard Error 2.1
|
-13.3 mm Hg
Standard Error 2.1
|
-15.3 mm Hg
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure
|
-3.0 mm Hg
Standard Error 1.2
|
-2.9 mm Hg
Standard Error 1.2
|
-3.5 mm Hg
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Heart Rate
|
-7.4 Beats per minute
Standard Error 2.0
|
-5.3 Beats per minute
Standard Error 2.0
|
9.7 Beats per minute
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Waist Circumference
|
-6.5 cm
Standard Error 1.3
|
-11.1 cm
Standard Error 1.3
|
-12.6 cm
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Total Cholesterol
|
-7.0 mg/dL
Standard Error 3.5
|
-9.7 mg/dL
Standard Error 3.6
|
-10.0 mg/dL
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in LDL Cholesterol
|
-3.3 mg/dL
Standard Error 3.1
|
-9.6 mg/dL
Standard Error 3.1
|
-9.4 mg/dL
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in HDL Cholesterol
|
-1.3 mg/dL
Standard Error 1.3
|
3.0 mg/dL
Standard Error 1.3
|
2.0 mg/dL
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Triglycerides
|
-16.3 mg/dL
Standard Error 5.7
|
-21.3 mg/dL
Standard Error 5.8
|
-14.4 mg/dL
Standard Error 5.7
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in C Reactive Protein
|
-0.4 mg/L
Standard Error 0.7
|
-2.0 mg/L
Standard Error 0.7
|
-3.0 mg/L
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Fasting Glucose
|
0.01 mg/dL
Standard Error 1.3
|
-5.2 mg/dL
Standard Error 1.3
|
-5.7 mg/dL
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in HbA1c
|
-0.3 percentage
Standard Error 0.03
|
-0.5 percentage
Standard Error 0.03
|
-0.6 percentage
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksOutcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Fasting Insulin
|
-1.5 uIU/mL
Standard Error 0.8
|
-1.1 uIU/mL
Standard Error 0.8
|
-1.5 uIU/mL
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksHOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement
Outcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in HOMA-IR
|
-0.4 mg/dL*µIU/mL/405
Standard Error 0.2
|
-0.3 mg/dL*µIU/mL/405
Standard Error 0.2
|
-0.4 mg/dL*µIU/mL/405
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksAll sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health. Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10. Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health.
Outcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary
|
4.4 T scores
Standard Error 1.0
|
2.1 T scores
Standard Error 1.0
|
3.4 T scores
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksAll sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health. Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10. Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health.
Outcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change 36-Item Short Form Survey (SF-36) - Mental Component Summary
|
0.8 T scores
Standard Error 1.3
|
4.5 T scores
Standard Error 1.3
|
6.4 T scores
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Randomization and 52 weeksPHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score.
Outcome measures
| Measure |
CMS-Alone
n=50 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 Participants
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Change in Patient Health Questionnaire (PHQ-9)
|
-1.8 score on a scale
Standard Error 0.6
|
-1.9 score on a scale
Standard Error 0.6
|
-1.5 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Systolic Blood Pressure
|
1.2 mm Hg
Standard Error 2.1
|
2.0 mm Hg
Standard Error 2.1
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=22 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=23 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Diastolic Blood Pressure
|
1.3 mm Hg
Standard Error 1.6
|
0.2 mm Hg
Standard Error 1.6
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Heart Rate
|
0 Beats per minute
Standard Error 1.4
|
2.1 Beats per minute
Standard Error 1.4
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Waist Circumference
|
-0.6 cm
Standard Error 0.8
|
-0.4 cm
Standard Error 0.8
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Total Cholesterol
|
3.4 mg/dL
Standard Error 3.3
|
0.4 mg/dL
Standard Error 3.3
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in LDL Cholesterol
|
2.3 mg/dL
Standard Error 2.8
|
-2.4 mg/dL
Standard Error 2.8
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in HDL Cholesterol
|
0.6 mg/dL
Standard Error 1.4
|
2.0 mg/dL
Standard Error 1.4
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Triglycerides
|
4.1 mg/dL
Standard Error 4.7
|
6.6 mg/dL
Standard Error 4.7
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in c-Reactive Protein
|
-0.8 mg/L
Standard Error 0.6
|
-0.6 mg/L
Standard Error 0.6
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Fasting Glucose
|
1.4 mg/dL
Standard Error 1.6
|
6.3 mg/dL
Standard Error 1.6
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in HbA1c
|
0.0 percentage
Standard Error 0.1
|
0.0 percentage
Standard Error 0.0
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksOutcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in Fasting Insulin
|
0.2 uIU/mL
Standard Error 1.0
|
0.5 uIU/mL
Standard Error 1.0
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksHOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement
Outcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Change in HOMA-IR
|
0.1 mg/dL*µIU/mL/405
Standard Error 0.2
|
0.3 mg/dL*µIU/mL/405
Standard Error 0.2
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksAll sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health. Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10. Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health.
Outcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: SF-36 - Physical Health Component
|
0.3 T scores
Standard Error 1.0
|
-1.2 T scores
Standard Error 1.0
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksAll sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health. Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10. Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health.
Outcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: SF-36 - Mental Health Component
|
-0.1 T scores
Standard Error 1.1
|
0.2 T scores
Standard Error 1.1
|
—
|
SECONDARY outcome
Timeframe: Re-randomization and 12 weeksPHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score.
Outcome measures
| Measure |
CMS-Alone
n=23 Participants
Lifestyle counseling on the visit schedule recommended by the Centers for Medicare and Medicaid Services (CMS).
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=22 Participants
CMS lifestyle counselling plus liraglutide 3.0 mg/d.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg/d: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
|---|---|---|---|
|
Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)
|
0.2 score on a scale
Standard Error 0.4
|
0.0 score on a scale
Standard Error 0.4
|
—
|
Adverse Events
CMS-Alone
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
CMS-Liraglutide
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Multi-Component Intervention
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
12-Week Extension Study: Phentermine Group
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
12-Week Extension Study: Placebo Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CMS-Alone
n=50 participants at risk
Lifestyle counseling, as currently recommended by the CMS.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 participants at risk
CMS lifestyle counselling plus liraglutide.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 participants at risk
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
12-Week Extension Study: Phentermine Group
n=22 participants at risk
After the 1-year trial, half the participants who join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling.
CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Phentermine 15 MG
|
12-Week Extension Study: Placebo Group
n=23 participants at risk
After the 1-year trial, half the participants who join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling.
CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Placebo Oral Tablet
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
2.0%
1/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Infections and infestations
Wound infection
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Nervous system disorders
Quadriplegic event
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.5%
1/22 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
Other adverse events
| Measure |
CMS-Alone
n=50 participants at risk
Lifestyle counseling, as currently recommended by the CMS.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
|
CMS-Liraglutide
n=50 participants at risk
CMS lifestyle counselling plus liraglutide.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
|
Multi-Component Intervention
n=50 participants at risk
CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet.
CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4.
|
12-Week Extension Study: Phentermine Group
n=22 participants at risk
After the 1-year trial, half the participants who join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling.
CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Phentermine 15 MG
|
12-Week Extension Study: Placebo Group
n=23 participants at risk
After the 1-year trial, half the participants who join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling.
CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
Placebo Oral Tablet
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
16.0%
8/50 • Number of events 8 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
32.0%
16/50 • Number of events 18 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
28.0%
14/50 • Number of events 18 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.5%
1/22 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.7%
2/23 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
20.0%
10/50 • Number of events 12 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
16.0%
8/50 • Number of events 8 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
9.1%
2/22 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.3%
1/23 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.7%
2/23 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
6.0%
3/50 • Number of events 3 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Infections and infestations
Tonsillopharyngitis
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
6.0%
3/50 • Number of events 3 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
6.0%
3/50 • Number of events 3 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.0%
4/50 • Number of events 4 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
2.0%
1/50 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.0%
4/50 • Number of events 5 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.0%
4/50 • Number of events 4 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.0%
3/50 • Number of events 3 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
10.0%
5/50 • Number of events 5 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
General disorders
Fatigue
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.0%
4/50 • Number of events 4 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
10.0%
5/50 • Number of events 6 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Skin and subcutaneous tissue disorders
Injection site irritation
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
10.0%
5/50 • Number of events 5 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
12.0%
6/50 • Number of events 6 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Gastroesophageal reflux disorder
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
12.0%
6/50 • Number of events 9 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
13.6%
3/22 • Number of events 3 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.3%
1/23 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Vomitting
|
6.0%
3/50 • Number of events 3 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
12.0%
6/50 • Number of events 8 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
10.0%
5/50 • Number of events 6 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
2/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
12.0%
6/50 • Number of events 9 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
14.0%
7/50 • Number of events 7 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
9.1%
2/22 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.3%
1/23 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal injury
|
12.0%
6/50 • Number of events 7 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
12.0%
6/50 • Number of events 6 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
24.0%
12/50 • Number of events 12 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.5%
1/22 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
21.7%
5/23 • Number of events 6 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
30.0%
15/50 • Number of events 16 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
34.0%
17/50 • Number of events 21 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Nausea
|
8.0%
4/50 • Number of events 4 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
36.0%
18/50 • Number of events 21 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
26.0%
13/50 • Number of events 17 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
9.1%
2/22 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.3%
1/23 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
4.5%
1/22 • Number of events 1 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.7%
2/23 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
Cardiac disorders
Heart Palpitations
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/22 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
8.7%
2/23 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
|
General disorders
Restlessness
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/50 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
9.1%
2/22 • Number of events 2 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
0.00%
0/23 • 52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
|
Additional Information
Dr. Thomas Wadden
The University of Pennsylvania Center for Weight and Eating Disorders
Phone: 215-746-5046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place