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

NCT00432679 | Completed Phase 3 Results

• 1 other identifier: AVD105248
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

rosiglitazone; Avandia; type 2 diabetes mellitus; diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Baseline (Day 0) and Week 16

• Change From Baseline After 16 Weeks of Treatment in Fasting Insulin

  Baseline (Day 0) and Week 16

• Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin

  Baseline (Day 0) and Week 16

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

  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 (Day 0) and Week 16

Study Arms (1)

arm 1

EXPERIMENTAL

study drug

Drug: Rosiglitazone (BRL49653C)

Interventions

Rosiglitazone (BRL49653C) DRUG

study drug

arm 1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Kanagawa, 212-0024, Japan

Location

GSK Investigational Site

Kumamoto, 862-0976, Japan

Location

GSK Investigational Site

Ōita, 870-0039, Japan

Location

GSK Investigational Site

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 8, 2007
• Study Start: May 24, 2006
• Primary Completion: March 28, 2007
• Study Completion: March 28, 2007
• Last Updated: December 12, 2022
• Results First Posted: February 8, 2019

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)