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

NCT02811484 | Withdrawn Phase 4

• 1 other identifier: 1512016843
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Body Weight

  baseline, 24 weeks

• Change in waist circumference

  baseline, 24 weeks

• Change in fasting glucose

  baseline, 24 weeks

• Change in fasting lipids

  baseline, 24 weeks

• Change in blood pressure

  baseline, 24 weeks

Study Arms (3)

Group 1

OTHER

Insulin titration and behavioral therapy.

Drug: Insulin Titration; Behavioral: Behavioral Therapy

Group 2

PLACEBO COMPARATOR

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

Drug: Exenatide-LAR plus Dapagliflozin placebo; Drug: Insulin Titration; Behavioral: Behavioral Therapy

Group 3

EXPERIMENTAL

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

Drug: Exenatide-LAR plus Dapagliflozin; Drug: Insulin Titration; Behavioral: Behavioral Therapy

Interventions

Exenatide-LAR plus Dapagliflozin placebo DRUG

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

Also known as: Bydureon, Farxiga

Group 2

Exenatide-LAR plus Dapagliflozin 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.

Also known as: Bydureon, Farxiga

Group 3

Insulin Titration DRUG

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

Also known as: Lantus, Levemir, Novolog, Lispro

Group 1; Group 2; Group 3

Behavioral Therapy BEHAVIORAL

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Comprehensive Weight Control Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Exenatide; dapagliflozin; Insulin Glargine; Insulin Detemir; Insulin Aspart; Insulin Lispro; Behavior Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Short-Acting; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alpana P Shukla, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 23, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)