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Completed

NCT Number: NCT00877890

A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

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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, Birmingham, Alabama, United States

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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 hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
  • Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
  • Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
  • 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 screening:
  • 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 ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
  • Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
  • Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
  • Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
  • Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
  • Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
  • 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

Treatment and study plan

exenatide once weekly

Drug

subcutaneous injection, 2.0mg, once a week

Other names: BYDUREON

exenatide twice daily

Drug

subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day

Other names: BYETTA

Primary outcomes

  1. Change in HbA1c From Baseline to Week 24

    Time frame: Day 1, Week 24

    Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline].

Secondary outcomes

  1. Percentage of Subjects Achieving HbA1c Target of <7%

    Time frame: Week 24

    Percentages of subjects achieving HbA1c target value of <7% at Week 24.

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

    Time frame: Week 24

    Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.

  3. Change in Fasting Plasma Glucose From Baseline to Week 24

    Time frame: Day 1, Week 24

    Change in fasting plasma glucose from baseline (Day 1) to Week 24.

  4. Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL

    Time frame: Week 24

    Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.

  5. Change in Body Weight From Baseline to Week 24

    Time frame: Day 1, Week 24

    Change in body weight from baseline (Day 1) to Week 24.

  6. Change in Sitting Systolic Blood Pressure From Baseline to Week 24

    Time frame: Day 1, Week 24

    Change in systolic blood pressure from baseline (Day 1) to Week 24.

  7. Change in Sitting Diastolic Blood Pressure From Baseline to Week 24

    Time frame: Day 1, Week 24

    Change in diastolic blood pressure from baseline (Day 1) to Week 24.

  8. Change in Total Cholesterol From Baseline to Week 24

    Time frame: Day 1, Week 24

    Change in total cholesterol from baseline (Day 1) to Week 24.

  9. Change in High-density Lipoprotein (HDL) From Baseline to Week 24

    Time frame: Day 1, Week 24

    Change in HDL from baseline (Day 1) to Week 24.

  10. Ratio of Triglycerides at Week 24 to Baseline

    Time frame: Day 1, Week 24

    Ratio of triglycerides (measured in mg/dL) at Week 24 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 Major Hypoglycemic Events

    Time frame: Day 1 to Week 24

    The major hypoglycemia category included 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 of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.

  12. Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events

    Time frame: Day 1 to Week 24

    The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 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, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 8, 2009
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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