Efficacy and Safety In Poorly Controlled Type 2 Diabetics

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00044460
• Collaborator: (none)
• Enrollment: 142
• Actual Duration (Months): 11.3

Study Details

Study Description

Brief Summary

The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: rosiglitazone	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: May 1, 2002
• Actual Primary Completion Date: Apr 10, 2003
• Actual Study Completion Date: Apr 10, 2003

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c from baseline to Week 24. []

Secondary Outcome Measures

1. Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Type 2 diabetes

• Drug-naive.

• Laboratory test result for HbA1c of greater than or equal to 10%.

• Written informed consent.

Exclusion criteria:

• Prior use of antidiabetic medications within 3 months of screening.

• Fluid retention (edema).

• Significant liver disease.

• Low red blood cells (anemia).

• Severe or unstable angina (chest pain).

• Congestive heart failure.

• Severe high blood pressure.

• Alcohol or drug abuse.

• Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

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.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00044460
• Other Study ID Numbers: 49653/326
• First Posted: Aug 30, 2002
• Last Update Posted: Oct 9, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Type 2 diabetes drug-naive
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Rosiglitazone

Study Results

No Results Posted as of Oct 9, 2017