Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes
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.
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.
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