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Completed

NCT Number: NCT00603239

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, New Westminster, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)

Other names: Byetta

Placebo

Drug

subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day

Primary outcomes

  1. Change in Glycosylated Hemoglobin (HbA1c)

    Time frame: baseline and 26 weeks

    Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)

Secondary outcomes

  1. Percentage of Patients Achieving HbA1c <= 7%

    Time frame: 26 weeks

    Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)

  2. Percentage of Patients Achieving HbA1c <= 6.5%

    Time frame: 26 weeks

    Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)

  3. Change in Fasting Serum Glucose (FSG)

    Time frame: baseline and 26 weeks

    Change in FSG from baseline to endpoint (26 weeks)

  4. Change in Body Weight

    Time frame: baseline and 26 weeks

    Change in body weight from baseline to endpoint (26 weeks)

  5. Change in Waist Circumference

    Time frame: baseline and 26 weeks

    Change in waist circumference from baseline to endpoint (26 weeks)

  6. Change in Beta-cell Function

    Time frame: baseline and 26 weeks

    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.

  7. Change in Insulin Sensitivity.

    Time frame: baseline and 26 weeks

    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).

  8. Number of Subjects Who Experienced an Episode of Minor Hypoglycemia

    Time frame: 26 weeks

    Overall number of subjects who experienced an episode of minor hypoglycemia.

  9. Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score

    Time frame: baseline and 26 weeks

    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."

  10. Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score

    Time frame: baseline and 26 weeks

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2008
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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