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

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02811484

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2016-06-01

Expected to finish

2018-12-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Type 2 diabetes
• BMI ≥27kg/m\^2
• Hemoglobin A1C 8-12%
• English speaking
• provided written consent
• on a stable dose of metformin and/or glitazone and/or alpha-glucosidase inhibitors for ≥ to 8 weeks

You may not qualify if…

• History of type 1 diabetes
• fasting c-peptide <.8 ng/ml
• eGFR <60 ml/min/1.73 m\^2
• urine albumin-to-creatinine ratio greater or equal to 300 mg/g
• AST/ALT greater or equal to 2.5 upper limits of normal
• history of infectious liver disease (HBV, HCV)
• creatine kinase greater or equal to 3 times the upper limits of normal
• unstable or serious cardiovascular, renal, or hepatic disease
• symptoms of severely uncontrolled diabetes
• history of more than 1 episode of severe/major hypoglycemia within 6 months, active/history of bladder cancer
• female patients who are pregnant or intending to become pregnant
• women who are breastfeeding
• personal/family history of medullary thyroid cancer or MEN2
• fasting triglyceride levels > 500 mg/dl
• history of confirmed pancreatitis
• known hypersensitivity or allergy to exenatide or dapagliflozin
• are currently enrolled in or discontinued within last 30 days from another study
• have any other condition that precludes the patient from following and completing the protocol
• history of diabetic ketoacidosis
• anti-diabetes medication other than those listed in the inclusion criteria within 8 weeks of screening
• history of previous bariatric surgery or planned bariatric surgery during the course of the study
• clinically significant abnormal free T4/TSH requiring initiation or adjustment of thyroid treatment

Where it is running

• Comprehensive Weight Control Center — New York, New York, United States

Full record on ClinicalTrials.gov

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