Clinical trial

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

Name

AVD105248

Description

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

Trial arms

Trial start

2006-05-24

Estimated PCD

2007-03-28

Trial end

2007-03-28

Status

Completed

Phase

Early phase I

Treatment

Rosiglitazone (BRL49653C)

study drug

Arms:

arm 1

Size

149

Primary endpoint

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

Baseline (Day 0) and Week 16

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 149, 'type': 'ACTUAL'}}

Updated at

2022-12-12

1 organization

1 product

2 indications

Organization

Product

Indication

Indication