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 has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00877890
First received: April 6, 2009
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide once weekly
Drug: exenatide twice daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c From Baseline to Week 24 [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline].


Secondary Outcome Measures:
  • Percentage of Subjects Achieving HbA1c Target of <7% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentages of subjects achieving HbA1c target value of <7% at Week 24.

  • Percentage of Subjects Achieving HbA1c Target of <=6.5% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.

  • Change in Fasting Plasma Glucose From Baseline to Week 24 [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose from baseline (Day 1) to Week 24.

  • Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.

  • Change in Body Weight From Baseline to Week 24 [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    Change in body weight from baseline (Day 1) to Week 24.

  • Change in Sitting Systolic Blood Pressure From Baseline to Week 24 [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    Change in systolic blood pressure from baseline (Day 1) to Week 24.

  • Change in Sitting Diastolic Blood Pressure From Baseline to Week 24 [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    Change in diastolic blood pressure from baseline (Day 1) to Week 24.

  • Change in Total Cholesterol From Baseline to Week 24 [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    Change in total cholesterol from baseline (Day 1) to Week 24.

  • Change in High-density Lipoprotein (HDL) From Baseline to Week 24 [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    Change in HDL from baseline (Day 1) to Week 24.

  • Ratio of Triglycerides at Week 24 to Baseline [ Time Frame: Day 1, Week 24 ] [ Designated as safety issue: No ]
    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.

  • Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: Yes ]
    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.

  • Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 254
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: exenatide once weekly
subcutaneous injection, 2.0mg, once a week
Other Name: BYDUREON
Active Comparator: 2 Drug: exenatide twice daily
subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day
Other Name: BYETTA

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877890

  Show 41 Study Locations
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00877890     History of Changes
Other Study ID Numbers: BCB108 (DURATION-5)
Study First Received: April 6, 2009
Results First Received: February 14, 2012
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
diabetes
exenatide once weekly
Byetta
Amylin
Lilly
Bydureon

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

ClinicalTrials.gov processed this record on October 23, 2014