NCT02811484

Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes

Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin. This research study is being done to investigate which of these commonly-used medications, medication combinations or increasing insulin dose is better.

Detailed description

This is a single center prospective, randomized, placebo-controlled trial in overweight/obese patients with insulin treated uncontrolled type 2 diabetes Eligible subjects willing to participate in the study will be randomized to one of 3 treatment groups: Group 1: Insulin titration + behavioral therapy Basal insulin titration upto 12 weeks with 2 U increment every 3 days (Fasting glucose goal \<110) based on self-monitored blood glucose. After 12 weeks, patients with HbA1c \>8% will switch to a basal bolus regimen. Group 2: Exenatide-LAR 2mg q week x 24 weeks + Dapagliflozin placebo x 52 weeks + titrated basal insulin +behavioral therapy. Group 3: Exenatide-LAR 2mg q week x 24 weeks plus Dapagliflozin 5mg QD x 2 weeks followed by 10mg QD x22 weeks +titrated basal insulin + behavioral therapy. Behavioral therapy will be delivered by registered dietitians and will include the BMIQ program -a web based medical weight loss program.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Exenatide-LAR plus Dapagliflozin placebo	Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.
DRUG	Exenatide-LAR plus Dapagliflozin	Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin 5 mg x 2 weeks, then 10 mg for 22 weeks and behavioral therapy.
DRUG	Insulin Titration	Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c\>8%
BEHAVIORAL	Behavioral Therapy	Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2016-06-23
• Last updated: 2017-03-03

Locations

1 site across 1 country: United States