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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2012

Interventions

  • Drug: placebo
    • subcutaneous injection, twice a day
  • Drug: exenatide
    • subcutaneous injection, twice a day, 10mcg

Arms, Groups and Cohorts

  • Placebo Comparator: 1
  • Experimental: 2

Clinical Trial Outcome Measures

Primary Measures

  • Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Percentage change in abdominal visceral fat

Secondary Measures

  • Percentage Change in Total Abdominal Fat From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Percentage change in total abdominal fat
  • Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Percentage change in subcutaneous abdominal fat
  • Change in HbA1c From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
  • Percentage of Patients With HbA1c <=7.0% at 6 Months
    • Time Frame: 6 months
    • Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
  • Change in Fasting Plasma Glucose From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in Fasting plasma glucose
  • Change in Weight From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in weight
  • Change in Systolic Blood Pressure From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in Systolic blood pressure
  • Change in Diastolic Blood Pressure From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in Diastolic blood pressure
  • Change in Total Cholesterol From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in total cholesterol
  • Change in Triglycerides From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in triglycerides
  • Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
    • Time Frame: baseline, 6 months
    • Change in HDL cholesterol
  • Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
    • Time Frame: baseline, 6 months
    • All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).

Participating in This Clinical Trial

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, 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chief Medical Officer, MD Eli Lilly and Company, Study Director, Eli Lilly and Company

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.