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A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
This study has been completed.

First Received on March 6, 2008.   Last Updated on June 17, 2011   History of Changes
Sponsor: Amylin Pharmaceuticals, Inc.
Collaborator: Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00637273
  Purpose

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and thiazolidinedione 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: thiazolidinedione
Drug: placebo tablet
Drug: placebo once weekly
Phase III

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:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
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: thiazolidinedione
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 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 DPP-4 inhibitor, SU, TZD, or 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, Inc.
Eli Lilly and Company
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, Inc.
  More Information

No publications provided by Amylin Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Porter, MD, Study Director, Amylin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00637273     History of Changes
Other Study ID Numbers: BCB106 (DURATION - 2)
Study First Received: March 6, 2008
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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 February 09, 2012