Diabetes Mellitus Clinical Trial
Official title:
A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects With Type 2 Diabetes
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.
Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known
as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key
feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic
basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome
proliferator-activated receptors, an effect that is associated with altered transcription of
genes capable of influencing carbohydrate and lipid metabolism.
Metformin hydrochloride is an oral antihyperglycemic drug not chemically or
pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been
shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits
hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its
use is associated with an improvement in tissue sensitivity to insulin. In accordance with
published algorithms for the use of combination therapy for the treatment of type 2
diabetes, physicians have traditionally combined metformin with other antidiabetic agents.
This study will determine the effect of a fixed-dose combination of metformin with
pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy.
Study participation is anticipated to be approximately 6.5 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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