Trial Outcomes & Findings for Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria (NCT NCT03331289)
NCT ID: NCT03331289
Last Updated: 2023-07-24
Results Overview
The difference in rate of EGP during the last hour of the study (from 240-300 minutes) between drug-treatment and placebo treatment studies represents the effect of drug treatment on EGP, which will be compared among the 3 acute drug treatments (exenatide; dapagliflozin; exenatide plus dapagliflozin this data includes change in EGP above baseline following dapagliflozin alone vs dapagliflozin/exenatide) with ANOVA.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
From baseline [-35 to 0min] to the last hour post-glucose load [240-300 minutes]
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
Type 2 Diabetes on Dapagliflozin
Patients will be randomized to receive dapagliflozin 10 mg daily, acutely and for 34 months.
|
Type 2 Diabetes on Oral Placebo
Randomly selected group of patients with type 2 diabetes who will receive oral placebo for dapagliflozin at the same dosing schedule as dapagliflozin
|
Type 2 Diabetes on Exenatide
patients ill be randomized to receive exenatide injections subcutaneously acutely and daily for 4 months.
|
Type 2 Diabetes on Exenatide Plus Dapagliflozin
patients will be randomized to receive exenatide injections plus dapagliflozin acutely and for 4 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
23
|
28
|
26
|
|
Overall Study
COMPLETED
|
25
|
15
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Placebo: Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Exenatide
n=25 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Exenatide: Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Dapagliflozin
n=25 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Dapagliflozin: Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Exenatide and Dapagliflozin
n=25 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Exenatide and Dapagliflozin: Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 3 • n=5 Participants
|
52 years
STANDARD_DEVIATION 3 • n=7 Participants
|
51 years
STANDARD_DEVIATION 2 • n=5 Participants
|
49 years
STANDARD_DEVIATION 2 • n=4 Participants
|
51 years
STANDARD_DEVIATION 3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
ENDOGENOUS GLUCOSE PRODUCTION [EGP]
|
2.30 mg/kg.min
STANDARD_DEVIATION 0.05 • n=5 Participants
|
2.33 mg/kg.min
STANDARD_DEVIATION 0.13 • n=7 Participants
|
2.27 mg/kg.min
STANDARD_DEVIATION 0.04 • n=5 Participants
|
2.41 mg/kg.min
STANDARD_DEVIATION 0.10 • n=4 Participants
|
2.33 mg/kg.min
STANDARD_DEVIATION 0.25 • n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline [-35 to 0min] to the last hour post-glucose load [240-300 minutes]Population: Type 2 diabetes
The difference in rate of EGP during the last hour of the study (from 240-300 minutes) between drug-treatment and placebo treatment studies represents the effect of drug treatment on EGP, which will be compared among the 3 acute drug treatments (exenatide; dapagliflozin; exenatide plus dapagliflozin this data includes change in EGP above baseline following dapagliflozin alone vs dapagliflozin/exenatide) with ANOVA.
Outcome measures
| Measure |
Placebo
n=15 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Placebo: Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Exenatide
n=25 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Exenatide: Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Dapagliflozin
n=25 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Dapagliflozin: Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Exenatide and Dapagliflozin
n=25 Participants
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Exenatide and Dapagliflozin: Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
|
|---|---|---|---|---|
|
Change in EGP From Baseline to Post-oral Glucose Load.
|
-0.03 mg/kg.min
Standard Error 0.02
|
-0.18 mg/kg.min
Standard Error 0.02
|
0.14 mg/kg.min
Standard Error 0.03
|
-0.08 mg/kg.min
Standard Error 0.03
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exenatide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dapagliflozin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Exenatide and Dapagliflozin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Placebo: Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Exenatide
n=25 participants at risk
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Exenatide: Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Dapagliflozin
n=25 participants at risk
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Dapagliflozin: Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
|
Exenatide and Dapagliflozin
n=25 participants at risk
we will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose conc compared to each agent alone.
Exenatide and Dapagliflozin: Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
|
|---|---|---|---|---|
|
Infections and infestations
Genital Mycosis
|
0.00%
0/15 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
0.00%
0/25 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
28.0%
7/25 • Number of events 7 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
16.0%
4/25 • Number of events 4 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
0.00%
0/15 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
16.0%
4/25 • Number of events 4 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
0.00%
0/25 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
8.0%
2/25 • Number of events 2 • 4 months
Adverse events collected during clinical evaluation and laboratory analyses
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place