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

Diabetes Mellitus, Type 2 Clinical Trial

— Dexlar  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02811484
• Other study ID #: 1512016843
• Status: Withdrawn
• Phase: Phase 4
• First received: June 17, 2016
• Last updated: March 1, 2017
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	Comprehensive Weight Control Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	To determine the efficacy of Exenatide-LAR and Exenatide-LAR plus dapagliflozin in lowering HbA1c compared with insulin titration in obese, insulin treated subjects with uncontrolled Type 2 Diabetes Mellitus at 24 weeks	baseline, 24 weeks
Secondary	Change in Body Weight	To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on body weight in obese, insulin treated subjects with uncontrolled T2DM	baseline, 24 weeks
Secondary	Change in waist circumference	To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on waist circumference in obese, insulin treated subjects with uncontrolled T2DM	baseline, 24 weeks
Secondary	Change in fasting glucose	To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting glucose (FG) in obese, insulin treated subjects with uncontrolled T2DM	baseline, 24 weeks
Secondary	Change in fasting lipids	To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting lipids in obese, insulin treated subjects with uncontrolled T2DM	baseline, 24 weeks
Secondary	Change in blood pressure	To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on blood pressure in obese, insulin treated subjects with uncontrolled T2DM	baseline, 24 weeks
Secondary	Change in total dose insulin	To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on total dose insulin in obese, insulin treated subjects with uncontrolled T2DM	baseline, 24 weeks