Trial Outcomes & Findings for Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD. (NCT NCT01784965)

Results Overview

Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

69 participants

Primary outcome timeframe

Baseline and 14 weeks

Results posted on

2017-04-21

Participant Flow

1 person qualified and enrolled in study but dropped out before being randomized to either group. Therefore is not counted in placebo or liraglutide group.

Participant milestones

Participant milestones
Measure	Placebo Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.	Liraglutide Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.
Overall Study STARTED	33	35
Overall Study COMPLETED	27	24
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.	Liraglutide Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.
Overall Study Withdrawal by Subject	6	3
Overall Study Adverse Event	0	8

Baseline Characteristics

Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=27 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.	Liraglutide n=24 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.	Total n=51 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 8 • n=99 Participants	58 years STANDARD_DEVIATION 7 • n=107 Participants	58 years STANDARD_DEVIATION 7.5 • n=206 Participants
Sex: Female, Male Female	17 Participants n=99 Participants	16 Participants n=107 Participants	33 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	8 Participants n=107 Participants	18 Participants n=206 Participants
Region of Enrollment United States	27 participants n=99 Participants	24 participants n=107 Participants	51 participants n=206 Participants
BMI	31.9 kg/m^2 STANDARD_DEVIATION 3.5 • n=99 Participants	31.9 kg/m^2 STANDARD_DEVIATION 2.7 • n=107 Participants	31.9 kg/m^2 STANDARD_DEVIATION 3.1 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 14 weeks

Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.	Liraglutide n=24 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.
Change in Weight Reported at 14 Weeks	-3.3 kg Interval -4.1 to -2.5	-6.8 kg Interval -7.8 to -5.9

SECONDARY outcome

Timeframe: Baseline, 14 weeks

Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.	Liraglutide n=24 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.
Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H	-7.3 pmol/l x4 h Interval -17.0 to 2.0	34 pmol/l x4 h Interval 21.0 to 48.0

SECONDARY outcome

Timeframe: Baseline, 14 weeks

Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.	Liraglutide n=24 Participants Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.
Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction	2.8 mg/dL Standard Deviation 35.9	-57.5 mg/dL Standard Deviation 44.2

Adverse Events

Liraglutide

Serious events: 8 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Liraglutide n=35 participants at risk Intolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35	Placebo n=33 participants at risk 0/33 0/33 0/33 0/33 0/33
Gastrointestinal disorders Intolerable gastrointestional side effects	8.6% 3/35 • Number of events 3	0.00% 0/33
Skin and subcutaneous tissue disorders injection site reaction	5.7% 2/35 • Number of events 2	0.00% 0/33
Respiratory, thoracic and mediastinal disorders pneumonia	2.9% 1/35 • Number of events 1	0.00% 0/33
Gastrointestinal disorders Gallstones	2.9% 1/35 • Number of events 1	0.00% 0/33
General disorders fall	2.9% 1/35 • Number of events 1	0.00% 0/33

Other adverse events

Other adverse events
Measure	Liraglutide n=35 participants at risk Intolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35	Placebo n=33 participants at risk 0/33 0/33 0/33 0/33 0/33
Investigations protocol deviation	2.9% 1/35 • Number of events 1	0.00% 0/33
Surgical and medical procedures elective back surgery	2.9% 1/35 • Number of events 1	0.00% 0/33
Investigations Family issues	2.9% 1/35 • Number of events 1	0.00% 0/33
Investigations Decided to withdraw	0.00% 0/35	18.2% 6/33 • Number of events 6

Additional Information

Gerald Reaven, Professor Emeritus

Stanford Universtiy

Phone: 650-724-3416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place