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Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
This study is currently recruiting participants.
Verified by Amylin Pharmaceuticals, Inc., March 2009
First Received: June 17, 2008   Last Updated: March 30, 2009   History of Changes
Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00701935
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: placebo
Drug: exenatide
Phase II

MedlinePlus related topics: Diabetes
Drug Information available for: Exenatide Metformin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Compare the effect of exenatide versus matching placebo on the percentage change in abdominal visceral fat content as measured by CT scan in overweight patients with type 2 diabetes who have failed to achieve adequate glycemic control with metformin [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the effect of exenatide versus placebo on abdominal visceral fat over (up to) 12 months of therapy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 94
Study Start Date: August 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: placebo
subcutaneous injection, twice a day, 10mcg
2: Experimental Drug: exenatide
subcutaneous injection, twice a day, 10mcg

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701935

Contacts
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559)

Locations
Canada
Research Site Not yet recruiting
Quebec, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Canada, Alberta
Research Site Recruiting
Calgary, Alberta, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Canada, British Columbia
Research Site Recruiting
Vancouver, British Columbia, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Research Site Recruiting
Victoria, British Columbia, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Canada, New Brunswick
Research Site Recruiting
Saint John, New Brunswick, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Canada, Ontario
Research Site Recruiting
Toronto, Ontario, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Research Site Recruiting
Ottawa, Ontario, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Research Site Recruiting
London, Ontario, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Canada, Quebec
Research Site Not yet recruiting
Chicoutimi, Quebec, Canada
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY (1-877-285-4559)        
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company ( Study Director )
Study ID Numbers: H8O-CA-GWCE
Study First Received: June 17, 2008
Last Updated: March 30, 2009
ClinicalTrials.gov Identifier: NCT00701935     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes mellitus
Amylin
Lilly

Study placed in the following topic categories:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Metformin
Amylin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009