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

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Glimepiride; Rosiglitazone

Criteria

Inclusion Criteria:

• type 2 diabetes mellitus

• HbA1c between 7.5% and 11.0% at screening

• FPG between 7.0mmol/L and 13.3mmol/L at screening and at randomization visit

• subject was treated with diet and/or exercise alone

• QTc<450mesc or QTc<480msec for patients with bundle branch block

• Body Mass Index (BMI) >19kg/m2

• Subject has given written informed consent

Exclusion Criteria:

• Documented history of significant hypersensitivity to thiazolidinediones, sulfonylureas, or compounds with similar chemical structures

• Ongoing edema or history of edema requiring pharmacological treatment in the 12 months prior to screening

• Presence of ischemic heart disease and/or peripheral arterial disease, or NYHA grade I-IV congestive heart failure

• Taking nitrates

• Clinically significant renal or hepatic disease

• Anemia

• Severe hypertriglyceridemia (TG>=5.65mmol/L)

• Use of oral corticosteroids and Nicotinic acid

• Systolic blood pressure <170mmHg, or diastolic blood pressure > 100mmHg while on anti-hypertensive treatment

• Hyperthyroidism requiring treatment

• Diagnosed macular edema

• Women who are lactating, pregnant, or planning to become pregnant

• Presence of an active cancer or recently treated for cancer

• Drug/alcohol abuse

• Unwilling or unable to comply with the procedures described in the protocol