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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):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637273
First received: March 6, 2008
Last updated: June 4, 2014
Last verified: June 2014

March 6, 2008
June 4, 2014
January 2008
February 2009   (final data collection date for primary outcome measure)
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].
To compare the effect of exenatide once weekly to those of sitagliptin and thiazolidinedione on glucose control, as measured by HbA1c, in subjects with type 2 diabetes mellitus. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00637273 on ClinicalTrials.gov Archive Site
  • 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.
  • To examine the safety and tolerability of exenatide once weekly compared to sitagliptin and thiazolidinedione in subjects with type 2 diabetes mellitus. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare the effects of exenatide once weekly to those achieved by sitagliptin and thiazolidinedione in subjects with type 2 diabetes mellitus on the following: *Body weight; *Parameters related to glycemic control [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare the effects of exenatide once weekly to those achieved by sitagliptin and thiazolidinedione in subjects with type 2 diabetes mellitus on the following: *Parameters related to cardiovascular health; *Patient reported outcomes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide once weekly
    subcutaneous injection, 2.0mg, once a week
  • Drug: sitagliptin
    oral tablet, 100mg, once a day
    Other Name: Januvia
  • Drug: pioglitazone
    oral tablet, 45mg, once a day
  • Drug: placebo tablet
    oral tablet, once a day
  • Drug: placebo once weekly
    subcutaneous injection, once a week
  • Experimental: 1
    Interventions:
    • Drug: exenatide once weekly
    • Drug: placebo tablet
  • Active Comparator: 2
    Interventions:
    • Drug: sitagliptin
    • Drug: placebo once weekly
  • Active Comparator: 3
    Interventions:
    • Drug: pioglitazone
    • Drug: placebo once weekly

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
514
July 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Mexico
 
NCT00637273
BCB106 (DURATION - 2)
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP