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

March 1, 2017 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Comprehensive Weight Control Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Insulin titration and behavioral therapy.
Drug: Insulin Titration
Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
Other Names:
  • Lantus, Levemir, Novolog, Lispro
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.
Placebo Comparator: Group 2
Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.
Drug: Insulin Titration
Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
Other Names:
  • Lantus, Levemir, Novolog, Lispro
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.
Drug: Exenatide-LAR plus Dapagliflozin placebo
Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.
Other Names:
  • Bydureon
  • Farxiga
Experimental: Group 3
Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.
Drug: Insulin Titration
Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
Other Names:
  • Lantus, Levemir, Novolog, Lispro
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.
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.
Other Names:
  • Bydureon
  • Farxiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: baseline, 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: baseline, 24 weeks
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
Change in waist circumference
Time Frame: baseline, 24 weeks
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
Change in fasting glucose
Time Frame: baseline, 24 weeks
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
Change in fasting lipids
Time Frame: baseline, 24 weeks
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
Change in blood pressure
Time Frame: baseline, 24 weeks
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
Change in total dose insulin
Time Frame: baseline, 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1512016843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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