Trial Outcomes & Findings for Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM (NCT NCT01107717)
NCT ID: NCT01107717
Last Updated: 2024-09-05
Results Overview
subjects will be followed for 3 years and the HbA1c measured at this time to provide the values for each arm as defined for the primary outcome of the study
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
318 participants
Primary outcome timeframe
at the end of the study (3 years)
Results posted on
2024-09-05
Participant Flow
Newly diagnosed T2DM participants
Participant milestones
| Measure |
Triple Therapy
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
metformin\\pioglitazone\\exenatide: metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c \< 6.5%
|
Conventional Therapy
sequential addition of metformin, glyburide and basal insulin
metformin, glyburide and glargine: subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c \< 6.5%
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
161
|
|
Overall Study
COMPLETED
|
103
|
114
|
|
Overall Study
NOT COMPLETED
|
54
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
Baseline characteristics by cohort
| Measure |
Triple Therapy
n=103 Participants
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
metformin\\pioglitazone\\exenatide: metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c \< 6.5%
|
Conventional Therapy
n=114 Participants
sequential addition of metformin, glyburide and basal insulin
metformin, glyburide and glargine: subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c \< 6.5%
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 1 • n=99 Participants
|
47 years
STANDARD_DEVIATION 1 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mexican Americans
|
73 participants
n=99 Participants
|
75 participants
n=107 Participants
|
148 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 participants
n=99 Participants
|
24 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=99 Participants
|
114 participants
n=107 Participants
|
217 participants
n=206 Participants
|
|
Fasting Plasma Glucose
|
203 mg/dl
STANDARD_DEVIATION 6 • n=99 Participants
|
200 mg/dl
STANDARD_DEVIATION 6 • n=107 Participants
|
201.5 mg/dl
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Diabetes Duration at start
|
4.8 Months
STANDARD_DEVIATION 0.5 • n=99 Participants
|
5.2 Months
STANDARD_DEVIATION 0.5 • n=107 Participants
|
5 Months
STANDARD_DEVIATION 0.5 • n=206 Participants
|
|
Body Mass Index (BMI)
|
36.4 kg/m^2
STANDARD_DEVIATION 1.1 • n=99 Participants
|
36.1 kg/m^2
STANDARD_DEVIATION 1.1 • n=107 Participants
|
36.25 kg/m^2
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Baseline HbA1c
|
9.0 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.2 • n=99 Participants
|
8.8 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.2 • n=107 Participants
|
8.9 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: at the end of the study (3 years)subjects will be followed for 3 years and the HbA1c measured at this time to provide the values for each arm as defined for the primary outcome of the study
Outcome measures
| Measure |
Triple Therapy
n=103 Participants
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
metformin\\pioglitazone\\exenatide: metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c \< 6.5%
|
Conventional Therapy
n=114 Participants
sequential addition of metformin, glyburide and basal insulin
metformin, glyburide and glargine: subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c \< 6.5%
|
|---|---|---|
|
HbA1c Level
|
6.9 percentage of glycated hemoglobin
Standard Error 0.1
|
6.4 percentage of glycated hemoglobin
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 3 yearsNumber of participants with HbA1c\>6.5% at 3 years
Outcome measures
| Measure |
Triple Therapy
n=103 Participants
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
metformin\\pioglitazone\\exenatide: metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c \< 6.5%
|
Conventional Therapy
n=114 Participants
sequential addition of metformin, glyburide and basal insulin
metformin, glyburide and glargine: subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c \< 6.5%
|
|---|---|---|
|
Treatment Failure
|
33 number of participants
|
59 number of participants
|
SECONDARY outcome
Timeframe: during the entire study (3 years)asymptomatic hypoglycemic events with documented PGC \< 60 mg/dl and sympotomatic hypoglycemia
Outcome measures
| Measure |
Triple Therapy
n=103 Participants
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
metformin\\pioglitazone\\exenatide: metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c \< 6.5%
|
Conventional Therapy
n=114 Participants
sequential addition of metformin, glyburide and basal insulin
metformin, glyburide and glargine: subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c \< 6.5%
|
|---|---|---|
|
Percentage of Patients With Reported Hypoglycemic Events
|
14 Participants
|
52 Participants
|
Adverse Events
Triple Therapy
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Conventional Therapy
Serious events: 0 serious events
Other events: 53 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Triple Therapy
n=103 participants at risk
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
metformin\\pioglitazone\\exenatide: metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c \< 6.5%
|
Conventional Therapy
n=114 participants at risk
sequential addition of metformin, glyburide and basal insulin
metformin, glyburide and glargine: subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c \< 6.5%
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.6%
14/103 • Number of events 14 • Adverse events were reported from baseline to study end (3 years) for each participant
|
45.6%
52/114 • Number of events 52 • Adverse events were reported from baseline to study end (3 years) for each participant
|
|
Gastrointestinal disorders
Nausea
|
25.2%
26/103 • Number of events 27 • Adverse events were reported from baseline to study end (3 years) for each participant
|
0.00%
0/114 • Adverse events were reported from baseline to study end (3 years) for each participant
|
|
Blood and lymphatic system disorders
Peripheral Edema
|
4.9%
5/103 • Number of events 5 • Adverse events were reported from baseline to study end (3 years) for each participant
|
0.88%
1/114 • Number of events 1 • Adverse events were reported from baseline to study end (3 years) for each participant
|
Additional Information
Muhammad Abdul-Ghani, MD
University of Texas Health Science Center at San Antonio
Phone: 210-557-1157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place