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

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Dapagliflozin; Exenatide; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria

• 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

Exclusion Criteria:

• 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