Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

• ClinicalTrials.gov Identifier: NCT00499707
• Recruitment Status: Completed
• First Posted: July 11, 2007
• Last Update Posted: March 21, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: July 9, 2007
• First Posted Date: July 11, 2007
• Last Update Posted Date: March 21, 2018
• Study Start Date: October 8, 2003
• Actual Primary Completion Date: December 1, 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 31, 2016): Change from baseline in hemoglobin A1c (HbA1c) at week 32. [ Time Frame: at 32 week ]
• Original Primary Outcome Measures (submitted: July 9, 2007): Change from baseline in hemoglobin A1c (HbA1c) at week 32. [ Time Frame: 32 Weeks ]
• Current Secondary Outcome Measures (submitted: August 31, 2016): Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks [ Time Frame: at 32 weeksInvalid value ]
• Original Secondary Outcome Measures (submitted: July 9, 2007): Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks [ Time Frame: 32 Weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
• Official Title: A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
• Brief Summary: The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2

Intervention

Drug: rosiglitazone maleate/metformin hydrochloride

rosiglitazone maleate/metformin hydrochloride

• Study Arms: Not Provided
• Publications *: Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 9, 2007): 453
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 16, 2004
• Actual Primary Completion Date: December 1, 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 to 70 years of age
• Clinical diagnosis of type 2 diabetes
• HbA1c >7.5% to 11%
• FPG <270mg/dL (15mmol)
• Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening

Exclusion Criteria:

• Clinically significant renal or hepatic disease
• Presence of anemia
• Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
• Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment
• Chronic disease requiring intermittent or chronic treatment with corticosteroids
• Any female lactating, pregnant, or planning to become pregnant
• History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
• Presence of acute or chronic metabolic acidosis
• History of diabetic ketoacidosis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Brazil, Canada, Korea, Republic of, Mexico, New Zealand, United States

Administrative Information

• NCT Number: NCT00499707
• Other Study ID Numbers: 712753/007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: March 2018