Conditions: Diabetes Mellitus, Type 2
Keywords: rosiglitazone/glimepiride, fix dose, type 2 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief 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).

Detailed description:
The antihyperglycemic effect of the thiazolidinedione (TZD) class of oral antidiabetic agents is due to their ability to increase insulin sensitivity at the cellular level, which in turn improves the ability of endogenous insulin to regulate glucose utilization by the tissues. Compounds of the sulfonylurea (SU) class act to stimulate insulin production by the pancreas, overcoming insulin resistance by increasing circulating insulin levels. The mechanisms of two kind OADs may be viewed as complementary, offering the opportunity for improved efficacy and durability of effect through coadministration of a TZD and a sulfonylurea.

Successful management of type 2 diabetes mellitus (T2DM) requires aggressive glycemic control starting at the earliest stages of the disease. Rosiglitazone/glimepiride combination therapy, with complementary mechanisms of action, has the potential to provide significant benefits over monotherapy as first line therapy. Treatment with rosiglitazone/glimepiride at this early stage of diabetes is expected to provide better glycemic control and allow a greater proportion of patients to achieve target glycemic goals than oral monotherapy.

This was a multicenter, randomized, double-blinded, parallel, study to compare the effects of treatment with rosiglitazone/glimepiride combination or glimepiride in drug naïve T2 DM patients.

Arms:
arm 1: 4mg/1mg, 4mg/2mg, 4mg/4mg arm 2: 1mg, 2mg, 4mg

Interventions: intervention 1: rosiglitazone/glimepiride fix dose combination intervention 2: glimepiride
Intervention descriptions: intervention 1: oral, once daily, dosage is titrated according to FPG and hypoglycemia events intervention 2: oral, once daily, dosage is titrated according to FPG and hypoglycemia

Protocol document: