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

Diabetes Mellitus, Type 2 Clinical Trial

Official 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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432679
• Other study ID #: AVD105248
• Status: Completed
• Phase: Phase 3
• Start date: May 24, 2006
• Est. completion date: March 28, 2007

Study information

• Verified date: November 2022
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 28, 2007
• Est. primary completion date: March 28, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosiglitazone (BRL49653C)
study drug

Locations

Country	Name	City	State
	GSK Investigational Site
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Oita

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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