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

June 17, 2008
June 6, 2014
August 2008
January 2012   (final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT00701935 on ClinicalTrials.gov Archive Site
  • 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).
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 ]
Not Provided
Not Provided
 
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: placebo
    subcutaneous injection, twice a day
  • Drug: exenatide
    subcutaneous injection, twice a day, 10mcg
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
NCT00701935
H8O-CA-GWCE
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Chief Medical Officer, MD Eli Lilly and Company Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP