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

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ClinicalTrials.gov Identifier: NCT02811484
Recruitment Status : Withdrawn (Inability to enroll due to the widespread use of both classes of drugs in patients with T2DM, including those on concomitant insulin therapy.)
First Posted : June 23, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Exenatide-LAR plus Dapagliflozin placebo Drug: Exenatide-LAR plus Dapagliflozin Drug: Insulin Titration Behavioral: Behavioral Therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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: 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

Drug: Insulin Titration
Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
Other Name: 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.

Experimental: Group 3
Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.
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

Drug: Insulin Titration
Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
Other Name: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811484


Locations
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United States, New York
Comprehensive Weight Control Center
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Alpana P Shukla, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02811484    
Other Study ID Numbers: 1512016843
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weill Medical College of Cornell University:
Obesity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists