A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

Study Overview
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Brief Summary
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This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

Official Title
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Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Rosiglitazone (BRL49653C)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function. Exclusion criteria: Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm 1<br>study drug | Drug: Rosiglitazone (BRL49653C)<br>* study drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample). | Baseline (Day 0) and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 | 
| Change From Baseline After 16 Weeks of Treatment in Fasting Insulin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 | 
| Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 | 
| Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 | 
| Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 | 
| Change From Baseline After 16 Weeks of Treatment in Adiponectin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 | 
| Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 | 
| Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment | The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above. | Up to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosiglitazone, Avandia, type 2 diabetes mellitus, diabetes