| Trial ID: | L3396 |
| Source ID: | NCT03419624
|
| Associated Drug: |
Dapagliflozin 10mg
|
| Title: |
The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin 10mg|DRUG: Exenatide 2 mg [Bydureon]|DRUG: Placebo Oral Tablet|DRUG: Placebo injection|DRUG: Insulin|DRUG: Metformin, if taken before
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline (week 0) to week 28, To compare the absolute change from baseline in HbA1c at week 28 between Dapagliflozin plus Exenatide, Placebo or Exenatide monotherapy added to high-dose intensive insulin therapy, 28 weeks | Secondary: Change in HbA1c from baseline (week 0) to week 14, To compare the absolute change in HbA1c from baseline at week 0 to week 14 between Dapagliflozin plus Exenatide, Placebo or Exenatide monotherapy added to high-dose intensive insulin therapy, 14 weeks|Change in total body weight from baseline (week 0) to week 14 and 28, To compare the change in total body weight from baseline at week 0 to week 14 and 28 between Dapagliflozin plus Exenatide, Placebo or Exenatide monotherapy added to high-dose intensive insulin therapy, 28 weeks|Change in BMI from baseline (week 0) to week 14 and 28, To compare the change in BMI from baseline at week 0 to week 14 and 28 between Dapagliflozin plus Exenatide, Placebo or Exenatide monotherapy added to high-dose intensive insulin therapy, 28 weeks|Change in FPG from baseline (week 0) to week 14 and 28, To compare the change in fasting plasma glucose (FPG) from baseline at week 0 to week 14 and 28 between Dapagliflozin plus Exenatide, Placebo or Exenatide monotherapy added to high-dose intensive insulin therapy, 28 weeks|Change in TDID from baseline (week 0) to week 14 and 28, To compare the change in total daily insulin dose (TDID) from baseline at week 0 to week 14 and 28 between Dapagliflozin plus Exenatide, Placebo or Exenatide monotherapy added to high-dose intensive insulin therapy, 28 weeks|Proportion of patients achieving HbA1c of ≤ 7% at week 28 compared to baseline, To compare the number of patients achieving HbA1c of ≤ 7% at week 28 compared to baseline at week 0 between Dapagliflozin plus Exenatide, Placebo or Exenatide monotherapy added to high-dose intensive insulin therapy, 28 weeks
|
| Sponsor/Collaborators: |
Sponsor: Universitätsklinikum Hamburg-Eppendorf | Collaborators: AstraZeneca
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
13
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-02-19
|
| Completion Date: |
2019-08-05
|
| Results First Posted: |
|
| Last Update Posted: |
2020-03-31
|
| Locations: |
Diabeteszentrum Oldenburg, Oldenburg, Lower Saxony, 23758, Germany|University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany|Diabetologische Schwerpunktpraxis Harburg, Hamburg, 21073, Germany|Gemeinschaftspraxis für Innere Medizin und Diabetologie, Hamburg, 22607, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03419624
|
