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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exenatide-LAR plus Dapagliflozin placebo
Exenatide-LAR plus Dapagliflozin
Insulin Titration
Behavioral Therapy
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Weight Control Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Placebo Comparator

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Insulin titration and behavioral therapy.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
June 17, 2016
Last Updated
March 1, 2017
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT02811484
Brief Title
Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes
Acronym
Dexlar
Official Title
Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to enroll due to the widespread use of both classes of drugs in patients with T2DM, including those on concomitant insulin therapy.
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Insulin titration and behavioral therapy.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.
Intervention Type
Drug
Intervention Name(s)
Exenatide-LAR plus Dapagliflozin placebo
Other Intervention Name(s)
Bydureon, Farxiga
Intervention Description
Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.
Intervention Type
Drug
Intervention Name(s)
Exenatide-LAR plus Dapagliflozin
Other Intervention Name(s)
Bydureon, Farxiga
Intervention Description
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
Intervention Name(s)
Insulin Titration
Other Intervention Name(s)
Lantus, Levemir, Novolog, Lispro
Intervention Description
Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Therapy
Intervention Description
Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
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
Time Frame
baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
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
Time Frame
baseline, 24 weeks
Title
Change in waist circumference
Description
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
Time Frame
baseline, 24 weeks
Title
Change in fasting glucose
Description
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
Time Frame
baseline, 24 weeks
Title
Change in fasting lipids
Description
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
Time Frame
baseline, 24 weeks
Title
Change in blood pressure
Description
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
Time Frame
baseline, 24 weeks
Title
Change in total dose insulin
Description
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
Time Frame
baseline, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alpana P Shukla, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Weight Control Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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