Skip to main content
OpenTrials
Completed

NCT Number: NCT00432679

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Kanagawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosiglitazone (BRL49653C)

Drug

study drug

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group

    Time frame: Baseline (Day 0) and Week 16

    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).

Secondary outcomes

  1. Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)

    Time frame: Baseline (Day 0) and Week 16

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

  2. Change From Baseline After 16 Weeks of Treatment in Fasting Insulin

    Time frame: Baseline (Day 0) and Week 16

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

  3. Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin

    Time frame: Baseline (Day 0) and Week 16

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

  4. Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: Baseline (Day 0) and Week 16

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

  5. Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)

    Time frame: Baseline (Day 0) and Week 16

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

  6. Change From Baseline After 16 Weeks of Treatment in Adiponectin

    Time frame: Baseline (Day 0) and Week 16

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

  7. Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Baseline (Day 0) and Week 16

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

  8. Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment

    Time frame: Up to Week 16

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 8, 2007
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.