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Safety and Efficacy of Exenatide as Monotherapy

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00381342
First received: September 25, 2006
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: exenatide
Drug: placebo
 Phase 3

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: Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline to Week 24


Secondary Outcome Measures:
  • Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 24 ] [ Designated as safety issue: No ]
    Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less

  • Change in fasting serum glucose (FSG) from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24 ] [ Designated as safety issue: No ]
    Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between

  • Change in body weight from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24 ] [ Designated as safety issue: No ]
    Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between

  • Change in glucose measurements from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 24 ] [ Designated as safety issue: No ]
    Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between

  • Changes in beta-cell function and insulin sensitivity from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24 ] [ Designated as safety issue: No ]
    Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between

  • Changes in fasting and 30, 60, 120 and 180-minute glucose measurements [ Time Frame: Immediately before glucose load, then 30, 60, 120, and 180 minutes post ] [ Designated as safety issue: No ]
    Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin


Enrollment: 233
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide 5 mcg/exenatide 5 mcg
Exenatide 5 mcg; then exenatide 5 mcg
 Drug: exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
Other Name: Byetta
Experimental: Exenatide 5 mcg/exenatide 10 mcg
Exenatide 5 mcg, then exenatide 10 mcg
 Drug: exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
Other Name: Byetta
Placebo Comparator: Placebo
Placebo in volumes equivalent to exenatide
 Drug: placebo
subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Treating diabetes with diet and exercise
  • HbA1c between 6.5% and 10.0%, inclusive
  • Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive

Exclusion Criteria:

  • Have previously completed or withdrawn from this study
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  • Have been treated with any antidiabetic agent
  • Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
  • Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381342

Locations
United States, Idaho
Research Site
Idaho Falls, Idaho, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
India
Research Site
Aligarh, India
Research Site
Bangalore, India
Research Site
Chennai, India
Research Site
Indore, India
Research Site
Karnal, India
Research Site
New Delhi, India
Research Site
Vellore, India
Puerto Rico
Research Site
Manati, Puerto Rico
Research Site
San Juan, Puerto Rico
Romania
Research Site
Alba Iulia, Romania
Research Site
Baia Mare, Romania
Research Site
Bucuresti, Romania
Research Site
Galati, Romania
Research Site
Oradea, Romania
Research Site
Targu Mures, Romania
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00381342     History of Changes
Other Study ID Numbers: H8O-MC-GWBJ
Study First Received: September 25, 2006
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation

Keywords provided by Amylin Pharmaceuticals, LLC.:
diabetes
exenatide
Amylin
Lilly
monotherapy

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

ClinicalTrials.gov processed this record on May 16, 2013