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Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00603239
First received: January 17, 2008
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.


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 in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)


Secondary Outcome Measures:
  • Percentage of Patients Achieving HbA1c <= 7% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)

  • Percentage of Patients Achieving HbA1c <= 6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)

  • Change in Fasting Serum Glucose (FSG) [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in FSG from baseline to endpoint (26 weeks)

  • Change in Body Weight [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline to endpoint (26 weeks)

  • Change in Waist Circumference [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in waist circumference from baseline to endpoint (26 weeks)

  • Change in Beta-cell Function [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.

  • Change in Insulin Sensitivity. [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).

  • Number of Subjects Who Experienced an Episode of Minor Hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Overall number of subjects who experienced an episode of minor hypoglycemia.

  • Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = "never true" to 5 = "always true."

  • Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: No ]
    EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.


Enrollment: 165
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide twice daily (BID) Drug: exenatide
subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
Other Name: Byetta
Placebo Comparator: Placebo Drug: placebo
subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, 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
  • If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
  • The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
  • The metformin dose has been stable for at least 90 days
  • Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
  • Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

Exclusion Criteria:

  • Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
  • Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
  • Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.

  • Are currently treated with any of the following excluded medications:

    • Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
    • Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
    • Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
    • Pramlintide acetate injection within 3 months prior to screening
    • Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
    • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603239

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States
United States, Ohio
Research Site
Mogadore, Ohio, United States
United States, Oregon
Research Site
Corvallis, Oregon, United States
Canada, British Columbia
Research Site
New Westminster, British Columbia, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, Ontario
Research Site
Ajax, Ontario, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Mexico
Research Site
Mexico City, Distrito Federal, Mexico
Research Site
Celaya, Guanajuato, Mexico
Research Site
Monterrey, Nuevo Leon, Mexico
Research Site
Chihuahua, Mexico
Research Site
Mexico City, Mexico
Romania
Research Site
Baia Mare, Romania
Research Site
Brasov, Romania
Research Site
Bucuresti, Romania
Research Site
Dolj, Romania
Research Site
Iasi, Romania
Research Site
Suceava, Romania
South Africa
Research Site
Johannesburg, South Africa
Research Site
Pretoria, South Africa
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, 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: NCT00603239     History of Changes
Other Study ID Numbers: H8O-MC-GWCG
Study First Received: January 17, 2008
Results First Received: July 20, 2010
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
South Africa: Medicines Control Council
Canada: Health Canada
Romania: National Medicines Agency

Keywords provided by Amylin Pharmaceuticals, LLC.:
diabetes
exenatide
metformin
thiazolidinedione
 Byetta
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 2,4-thiazolidinedione
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013