Trial Outcomes & Findings for Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function (NCT NCT00845182)
NCT ID: NCT00845182
Last Updated: 2018-01-18
Results Overview
Effect of Pioglitazone, Exenatide and combined Pioglitazone and Exenatide on body weight and beta cell function
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2018-01-18
Participant Flow
Participant milestones
| Measure |
Pioglitazone
Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
|
Exenatide
Exenatide: 15 subjects will be randomized to receive Exenatide
|
Pioglitazone and Exentatide
Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
6
|
Reasons for withdrawal
| Measure |
Pioglitazone
Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
|
Exenatide
Exenatide: 15 subjects will be randomized to receive Exenatide
|
Pioglitazone and Exentatide
Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=13 Participants
Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
|
Exenatide
n=15 Participants
Exenatide: 15 subjects will be randomized to receive Exenatide
|
Pioglitazone and Exentatide
n=15 Participants
Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
54.3 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
54.2 years
STANDARD_DEVIATION 8.02 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
15 participants
n=206 Participants
|
43 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: we analyzed the weight at the end of study completion
Effect of Pioglitazone, Exenatide and combined Pioglitazone and Exenatide on body weight and beta cell function
Outcome measures
| Measure |
PIOGLITAZONE
n=10 Participants
PIO therapy led to a weigh gain of 5.5 kg
|
EXENATIDE
n=11 Participants
PIO therapy led to a weigh loss of 2.4 kg
|
PIOGLITAZONE and EXNATIDE
n=9 Participants
Combinatiton of PIoglitazone and Exenatide led to weight gain of 2.7 kg
|
|---|---|---|---|
|
Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight
|
5.5 kg
Standard Deviation 7.3
|
2.4 kg
Standard Deviation 2.8
|
2.7 kg
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: There was a greater improvement in HbA1c from baseline after combined treatment with Pioglitazone and Exenatide when compared with either therapy alone.
change in HbA1c was measured before and after treatment in three groups
Outcome measures
| Measure |
PIOGLITAZONE
n=10 Participants
PIO therapy led to a weigh gain of 5.5 kg
|
EXENATIDE
n=11 Participants
PIO therapy led to a weigh loss of 2.4 kg
|
PIOGLITAZONE and EXNATIDE
n=9 Participants
Combinatiton of PIoglitazone and Exenatide led to weight gain of 2.7 kg
|
|---|---|---|---|
|
HbA1c
|
1.37 percent point decrease from baseline
Standard Deviation 0.68
|
1.09 percent point decrease from baseline
Standard Deviation 0.68
|
1.91 percent point decrease from baseline
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data were not collected for this analysis
Effect pioglitazone, exenatide, and pioglitazone plus exenatide on * Insulin sensitivity * Inflammatory cytokines * glucagon and free fatty acids * plasma lipids measured over a 6 month period
Outcome measures
Outcome data not reported
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Exenatide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pioglitazone and Exentatide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=12 participants at risk
Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
|
Exenatide
n=15 participants at risk
Exenatide: 15 subjects will be randomized to receive Exenatide
|
Pioglitazone and Exentatide
n=15 participants at risk
Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
|
|---|---|---|---|
|
General disorders
weight gain
|
16.7%
2/12 • Number of events 2 • Patients were followed for 6 months.
|
0.00%
0/15 • Patients were followed for 6 months.
|
6.7%
1/15 • Number of events 1 • Patients were followed for 6 months.
|
|
General disorders
nausea
|
0.00%
0/12 • Patients were followed for 6 months.
|
6.7%
1/15 • Number of events 1 • Patients were followed for 6 months.
|
0.00%
0/15 • Patients were followed for 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place