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Completed

NCT Number: NCT00637273

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

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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, Bangalore, India

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has been diagnosed with type 2 diabetes mellitus
  • Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
  • Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
  • Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
  • Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
  • Hormone replacement therapy (female subjects)
  • Oral contraceptives (female subjects)
  • Antihypertensive agents
  • Lipid-lowering agents
  • Thyroid replacement therapy
  • Antidepressant agents
  • Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents

Exclusion criteria

  • Has been previously exposed to exenatide once weekly
  • Has donated blood within 60 days of study start or is planning to donate blood during the study
  • Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
  • Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
  • Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
  • Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
  • Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
  • Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
  • Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
  • Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use

Treatment and study plan

exenatide once weekly

Drug

subcutaneous injection, 2.0mg, once a week

Sitagliptin

Drug

oral tablet, 100mg, once a day

Other names: Januvia

pioglitazone

Drug

oral tablet, 45mg, once a day

Placebo Tablet

Drug

oral tablet, once a day

Placebo Once Weekly

Drug

subcutaneous injection, once a week

Primary outcomes

  1. Change in HbA1c From Baseline to Week 26

    Time frame: Day 1, Week 26

    Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].

Secondary outcomes

  1. Percentage of Subjects Achieving HbA1c Target of <7% at Week 26

    Time frame: Week 26

    Percentages of subjects achieving HbA1c target values of <7% at Week 26.

  2. Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26

    Time frame: Week 26

    Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.

  3. Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26

    Time frame: Week 26

    Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.

  4. Change in Body Weight From Baseline to Week 26

    Time frame: Day 1, Week 26

    Change in body weight from baseline (Day 1) to Week 26.

  5. Change in Fasting Plasma Glucose From Baseline to Week 26

    Time frame: Day 1, Week 26

    Change in fasting plasma glucose from baseline (Day 1) to Week 26.

  6. Change in Systolic Blood Pressure From Baseline to Week 26

    Time frame: Day 1, Week 26

    Change in systolic blood pressure from baseline (Day 1) to Week 26.

  7. Change in Diastolic Blood Pressure From Baseline to Week 26

    Time frame: Day 1, Week 26

    Change in diastolic blood pressure from baseline (Day 1) to Week 26.

  8. Change in Fasting Total Cholesterol From Baseline to Week 26

    Time frame: Day 1, Week 26

    Change in fasting total cholesterol from baseline (Day 1) to Week 26.

  9. Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26

    Time frame: Day 1, Week 26

    Change in fasting HDL from baseline (Day 1) to Week 26.

  10. Ratio of Fasting Triglycerides at Week 26 to Baseline

    Time frame: Day 1, Week 26

    Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

  11. Assessment on Event Rate of Treatment-emergent Hypoglycemic Events

    Time frame: Day 1 to Week 26

    Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 17, 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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