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) - Full Text View

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Exenatide Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

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):

Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14.

Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. Epub 2010 Jun 26.

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