BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-11

Study Completion Date

2007-05-31

Brief Summary

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This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus.
* Managed by diet therapy.
* Must have adequate blood, liver and kidney function.

Exclusion Criteria

* Serious cardiovascular disease or serious hepatic disease.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Fukuoka, , Japan

Site Status

GSK Investigational Site

Fukushima, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Ibaraki, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kyoto, , Japan

Site Status

GSK Investigational Site

Nagano, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Saitama, , Japan

Site Status

GSK Investigational Site

Shizuoka, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

, ,

Site Status

Countries

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Japan

References

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Kikuchi M, Kaku K, Odawara M, Momomura S, Ishii R. Efficacy and tolerability of rosiglitazone and pioglitazone in drug-naive Japanese patients with type 2 diabetes mellitus: a double-blind, 28 weeks' treatment, comparative study. Curr Med Res Opin. 2012 Jun;28(6):1007-16. doi: 10.1185/03007995.2012.694361. Epub 2012 Jun 6.

Reference Type BACKGROUND

PMID: 22587483 (View on PubMed)

MacDonald MR, Petrie MC, Home PD, Komajda M, Jones NP, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock SJ, Curtis PS, McMurray JJ. Incidence and prevalence of unrecognized myocardial infarction in people with diabetes: a substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. Diabetes Care. 2011 Jun;34(6):1394-6. doi: 10.2337/dc10-2398. Epub 2011 May 11.

Reference Type BACKGROUND

PMID: 21562320 (View on PubMed)

Study Documents

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