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

This study has been terminated.
(Enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00701935
First received: June 17, 2008
Last updated: June 6, 2014
Last verified: June 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Percentage change in abdominal visceral fat


Secondary Outcome Measures:
  • Percentage Change in Total Abdominal Fat From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Percentage change in total abdominal fat

  • Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Percentage change in subcutaneous abdominal fat

  • Change in HbA1c From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in Fasting plasma glucose

  • Change in Weight From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Change in weight

  • Change in Systolic Blood Pressure From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
    Change in Systolic blood pressure

  • Change in Diastolic Blood Pressure From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
    Change in Diastolic blood pressure

  • Change in Total Cholesterol From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Change in total cholesterol

  • Change in Triglycerides From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Change in triglycerides

  • Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Change in HDL cholesterol

  • Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 80
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
subcutaneous injection, twice a day
Experimental: 2 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, 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701935

Locations
United States, Arizona
Research Site
Temple, Arizona, United States
United States, Colorado
Research Site
Colorado Springs, Colorado, United States
United States, Hawaii
Research Site
Honolulu, Hawaii, United States
United States, Nebraska
Research Site
Bellevue, Nebraska, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Research Site
Saint John, New Brunswick, Canada
Canada, Ontario
Research Site
Brampton, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Chicoutimi, Quebec, Canada
Research Site
Pointe-Claire, Quebec, Canada
Canada
Research Site
Quebec, Canada
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company Eli Lilly and Company
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00701935     History of Changes
Other Study ID Numbers: H8O-CA-GWCE
Study First Received: June 17, 2008
Results First Received: January 11, 2013
Last Updated: June 6, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
diabetes mellitus
Amylin
Lilly

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

ClinicalTrials.gov processed this record on October 20, 2014