Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00279045

Purpose

The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Non-Insulin-Dependent Diabetes Mellitus	Drug: Rosiglitazone Drug: glyburide Drug: metformin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus

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: Glyburide Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Time from randomization to the primary action point (monotherapy failure).

Secondary Outcome Measures:

Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).

Estimated Enrollment:	4100
Study Start Date:	January 2000

Intervention Details:

Other Names:

metformin
Rosiglitazone
glyburide

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Newly diagnosed patients (< 3years) with type 2 diabetes.
Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

History of lactic acidosis.
Anemia (<11g for males, <10 g for females).
Unstable or severe NY Heart Association-class 3 or 4.
Any NY Heart Association congestive heart failure.
Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279045

Show 476 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

Publications:

Viberti G, Lachin J, Holman R, Zinman B, Haffner S, Kravitz B, Heise MA, Jones NP, O'Neill MC, Freed MI, Kahn SE, Herman WH; for the ADOPT Study Group. A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabet Med. 2006 Dec;23(12):1289-94.

Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. Epub 2006 Dec 4. Erratum in: N Engl J Med. 2007 Mar 29;356(13):1387-8.

Kahn SE, Zinman B, Haffner SM, O'Neill MC, Kravitz BG, Yu D, Freed MI, Herman WH, Holman RR, Jones NP, Lachin JM, Viberti GC; ADOPT Study Group. Obesity is a major determinant of the association of C-reactive protein levels and the metabolic syndrome in type 2 diabetes. Diabetes. 2006 Aug;55(8):2357-64.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lachin JM, Viberti G, Zinman B, Haffner SM, Aftring RP, Paul G, Kravitz BG, Herman WH, Holman RR, Kahn SE; ADOPT Study Group. Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy. Clin J Am Soc Nephrol. 2011 May;6(5):1032-40. Epub 2011 Mar 31.

Kahn SE, Haffner SM, Viberti G, Herman WH, Lachin JM, Kravitz BG, Yu D, Paul G, Holman RR, Zinman B; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone decreases C-reactive protein to a greater extent relative to glyburide and metformin over 4 years despite greater weight gain: observations from a Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2010 Jan;33(1):177-83. Epub 2009 Oct 6.

Kahn SE, Zinman B, Lachin JM, Haffner SM, Herman WH, Holman RR, Kravitz BG, Yu D, Heise MA, Aftring RP, Viberti G; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2008 May;31(5):845-51. Epub 2008 Jan 25.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00279045 History of Changes
Other Study ID Numbers:	49653/048
Study First Received:	January 17, 2006
Last Updated:	March 17, 2011
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

type 2 diabetes monotherapy treatment naive

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone

Glyburide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012