Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

NCT00701935 | Terminated Phase 2 Results

• 1 other identifier: H8O-CA-GWCE
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 17

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; Amylin; Lilly

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months

  Percentage change in abdominal visceral fat

  baseline, 6 months

Secondary Outcomes (12)

• Percentage Change in Total Abdominal Fat From Baseline to 6 Months

  baseline, 6 months

• Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months

  baseline, 6 months

• Change in HbA1c From Baseline to 6 Months

  baseline, 6 months

• Percentage of Patients With HbA1c <=7.0% at 6 Months

  6 months

• Change in Fasting Plasma Glucose From Baseline to 6 Months

  baseline, 6 months

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: placebo

2

EXPERIMENTAL

Drug: exenatide

Interventions

placebo DRUG

subcutaneous injection, twice a day

1

exenatide DRUG

subcutaneous injection, twice a day, 10mcg

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 85 years of age, inclusive.
• Patients with type 2 diabetes
• Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1
• Patients have HbA1c of 7.0% to 8.9%, inclusive.
• Patients have a body mass index \>27 kg/m2 and \<40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index \>=25 kg/m2 is acceptable as the lower limit.
• Patients have a history of stable body weight (not varying by \>2 kg in the 3 months prior to Visit 1).
• Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit 1.
• Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.

You may not qualify if:

• Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
• Have a history of renal transplantation, or are currently receiving renal dialysis.
• Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
• Have known hemoglobinopathy or clinically significant, chronic anemia.
• Known or are likely to become transfusion dependent during the study.
• Have active, symptomatic proliferative retinopathy.
• Are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use of macrolide antibiotics)
• Have severe gastrointestinal disease, including gastroparesis.
• Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 months immediately prior to Visit 1.
• Have taken exenatide, liraglutide or any other GLP-1 receptor agonist in the past 6 months, either in a clinical study or as commercially available medication. Patients with known allergy to exenatide should be excluded.
• Have used any prescription or over the counter drug to promote weight loss within 3 months prior to Visit 1, or intend to use such a drug during the study. (Examples: Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Acomplia \[rimonabant\]).
• Have participated in a structured weight loss program within 3 months prior to Visit 1, or intend to participate in such a plan during this study.
• Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides.
• Are taking warfarin, or a coumarol derivative.

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (17)

Research Site

Temple, Arizona, United States

Location

Research Site

Colorado Springs, Colorado, United States

Location

Research Site

Honolulu, Hawaii, United States

Location

Research Site

Bellevue, Nebraska, United States

Location

Research Site

Las Vegas, Nevada, United States

Location

Research Site

Calgary, Alberta, Canada

Location

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

Victoria, British Columbia, Canada

Location

Research Site

Winnipeg, Manitoba, Canada

Location

Research Site

Saint John, New Brunswick, Canada

Location

Research Site

Brampton, Ontario, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

Ottawa, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Chicoutimi, Quebec, Canada

Location

Research Site

Pointe-Claire, Quebec, Canada

Location

Research Site

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Limitations and Caveats

The dropout rate in the study was higher than anticipated (of 80 patients randomized, only 53 completed Study Period II), and enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.

Results Point of Contact

• Title: Peter Ohman, Medical Science Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Chief Medical Officer, MD Eli Lilly and Company

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 10, 2015
• Results First Posted: February 13, 2013

Record last verified: 2015-03

Locations

CA (12); US (5)