Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy and Safety of Fixed-dose Rosiglitazone/Glimepiride Combination Therapy With Glimepiride Monotherapy for 24 Weeks in Drug Naive Subjects With Type 2 Diabetes
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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