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Clinical Trial Details

Trial ID: L5181
Source ID: NCT02811484
Associated Drug: Exenatide-Lar Plus Dapagliflozin Placebo
Title: Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes
Acronym: Dexlar
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Exenatide-LAR plus Dapagliflozin placebo|DRUG: Exenatide-LAR plus Dapagliflozin|DRUG: Insulin Titration|BEHAVIORAL: Behavioral Therapy
Outcome Measures: Primary: Change in HbA1c, To determine the efficacy of Exenatide-LAR and Exenatide-LAR plus dapagliflozin in lowering HbA1c compared with insulin titration in obese, insulin treated subjects with uncontrolled Type 2 Diabetes Mellitus at 24 weeks, baseline, 24 weeks | Secondary: Change in Body Weight, To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on body weight in obese, insulin treated subjects with uncontrolled T2DM, baseline, 24 weeks|Change in waist circumference, To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on waist circumference in obese, insulin treated subjects with uncontrolled T2DM, baseline, 24 weeks|Change in fasting glucose, To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting glucose (FG) in obese, insulin treated subjects with uncontrolled T2DM, baseline, 24 weeks|Change in fasting lipids, To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting lipids in obese, insulin treated subjects with uncontrolled T2DM, baseline, 24 weeks|Change in blood pressure, To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on blood pressure in obese, insulin treated subjects with uncontrolled T2DM, baseline, 24 weeks|Change in total dose insulin, To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on total dose insulin in obese, insulin treated subjects with uncontrolled T2DM, baseline, 24 weeks
Sponsor/Collaborators: Sponsor: Weill Medical College of Cornell University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-06
Completion Date: 2018-12
Results First Posted:
Last Update Posted: 2017-03-03
Locations: Comprehensive Weight Control Center, New York, New York, 10065, United States
URL: https://clinicaltrials.gov/show/NCT02811484