Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Rosiglitazone; Drug: glyburide; Drug: metformin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4426 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
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
Study Start Date :	January 3, 2000
Actual Primary Completion Date :	June 1, 2006
Actual Study Completion Date :	June 19, 2006

Arms and Interventions

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Intervention Details:

• Drug: Rosiglitazone
• Drug: glyburide
• Drug: metformin
  Other Names:

  • glyburide
  • Rosiglitazone

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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).

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Informed Consent Form 

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:

A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care, Vol 25, No. 10, October, 2002.

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; 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.

Zinman B, Kahn SE, Haffner SM, O'Neill MC, Heise MA, Freed MI; ADOPT Study Group. Phenotypic characteristics of GAD antibody-positive recently diagnosed patients with type 2 diabetes in North America and Europe. Diabetes. 2004 Dec;53(12):3193-200.

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. doi: 10.2215/CJN.09291010. 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. doi: 10.2337/dc09-1661. 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. doi: 10.2337/dc07-2270. Epub 2008 Jan 25.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00279045 History of Changes
Other Study ID Numbers:	49653/048
First Posted:	January 19, 2006
Last Update Posted:	November 29, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL:	http://

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; Metformin; Glyburide; Hypoglycemic Agents; Physiological Effects of Drugs