Efficacy and Safety In Poorly Controlled Type 2 Diabetics
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
1 other identifier
interventional
142
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started May 2002
Shorter than P25 for phase_4 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 29, 2002
CompletedFirst Posted
Study publicly available on registry
August 30, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2003
CompletedOctober 9, 2017
October 1, 2017
11 months
August 29, 2002
October 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline to Week 24.
Secondary Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Drug-naive.
- Laboratory test result for HbA1c of greater than or equal to 10%.
- Written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (2)
Abstract: The Effects of Rosiglitazone in Poorly-Controlled, Drug-Naive Patients with Type 2 Diabetes Mellitus, KATHLEEN L. WYNE, ALEXANDER R. COBITZ, BRIAN R. WATERHOUSE, LEANNE J. STROW. Dallas, TX; King of Prussia, PA; Orlando, FL; USA. 64th Annual Scientific Sessions of the American Diabetes Association. 6/4/2004
RESULTWyne KL, Cobitz AR, Waterhouse BR, Strow LJ. The effects of rosiglitazone in poorly-controlled drug-naive patients with type 2 diabetes mellitus. Diabetes 2004;53(Suppl 2):A152. Poster 639 presented at ADA
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2002
First Posted
August 30, 2002
Study Start
May 1, 2002
Primary Completion
April 10, 2003
Study Completion
April 10, 2003
Last Updated
October 9, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.