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An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients

NCT01453049 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2012-03-27

Study results available
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Summary

The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose combination tablet will safely and effectively control glycemia as first-line oral therapy in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in lowering Glycosylated Hemoglobin (HbA1c).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

rosiglitazone/glimepiride fix dose combination

oral, once daily, dosage is titrated according to FPG and hypoglycemia events

DRUG

glimepiride

oral, once daily, dosage is titrated according to FPG and hypoglycemia

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453049 on ClinicalTrials.gov