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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 has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00637273
First received: March 6, 2008
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: exenatide once weekly
Drug: sitagliptin
Drug: pioglitazone
Drug: placebo tablet
Drug: placebo once weekly
 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: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in HbA1c From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].


Secondary Outcome Measures:
  • Percentage of Subjects Achieving HbA1c Target of <7% at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percentages of subjects achieving HbA1c target values of <7% at Week 26.

  • Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.

  • Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.

  • Change in Body Weight From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    Change in body weight from baseline (Day 1) to Week 26.

  • Change in Fasting Plasma Glucose From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose from baseline (Day 1) to Week 26.

  • Change in Systolic Blood Pressure From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    Change in systolic blood pressure from baseline (Day 1) to Week 26.

  • Change in Diastolic Blood Pressure From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    Change in diastolic blood pressure from baseline (Day 1) to Week 26.

  • Change in Fasting Total Cholesterol From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    Change in fasting total cholesterol from baseline (Day 1) to Week 26.

  • Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    Change in fasting HDL from baseline (Day 1) to Week 26.

  • Ratio of Fasting Triglycerides at Week 26 to Baseline [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
    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.

  • Assessment on Event Rate of Treatment-emergent Hypoglycemic Events [ Time Frame: Day 1 to Week 26 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 514
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: February 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
Drug: placebo tablet
oral tablet, once a day
Active Comparator: 2 Drug: sitagliptin
oral tablet, 100mg, once a day
Other Name: Januvia
Drug: placebo once weekly
subcutaneous injection, once a week
Active Comparator: 3 Drug: pioglitazone
oral tablet, 45mg, once a day
Drug: placebo once weekly
subcutaneous injection, once a week

  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 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:

    1. Hormone replacement therapy (female subjects)
    2. Oral contraceptives (female subjects)
    3. Antihypertensive agents
    4. Lipid-lowering agents
    5. Thyroid replacement therapy
    6. Antidepressant agents
    7. 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:

    1. 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
    2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
    3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
    4. 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
    5. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637273

  Show 62 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  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: NCT00637273     History of Changes
Other Study ID Numbers: BCB106 (DURATION - 2)
Study First Received: March 6, 2008
Results First Received: February 14, 2012
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
diabetes
exenatide once weekly
Byetta
sitagliptin
Januvia
 thiazolidinedione
Amylin
Lilly
Pioglitazone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Exenatide
2,4-thiazolidinedione
Sitagliptin
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013