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

NCT ID: NCT02811484

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Insulin titration and behavioral therapy.

Group Type: OTHER

Insulin Titration

Intervention Type: DRUG

Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c\>8%

Behavioral Therapy

Intervention Type: BEHAVIORAL

Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.

Group 2

Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.

Group Type: PLACEBO_COMPARATOR

Exenatide-LAR plus Dapagliflozin placebo

Intervention Type: DRUG

Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.

Insulin Titration

Intervention Type: DRUG

Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c\>8%

Behavioral Therapy

Intervention Type: BEHAVIORAL

Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.

Group 3

Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.

Group Type: EXPERIMENTAL

Exenatide-LAR plus Dapagliflozin

Intervention Type: DRUG

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.

Insulin Titration

Intervention Type: DRUG

Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c\>8%

Behavioral Therapy

Intervention Type: BEHAVIORAL

Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.

Interventions

Exenatide-LAR plus Dapagliflozin placebo

Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.

Intervention Type: 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.

Intervention Type: DRUG

Insulin Titration

Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c\>8%

Intervention Type: DRUG

Behavioral Therapy

Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.

Intervention Type: BEHAVIORAL

Other Intervention Names

Bydureon; Farxiga; Bydureon; Farxiga; Lantus, Levemir, Novolog, Lispro

Eligibility 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

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alpana P Shukla, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Comprehensive Weight Control Center

New York, New York, United States

Countries

United States

Other Identifiers

1512016843

Identifier Type: -

Identifier Source: org_study_id