Type 2 Diabetes Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel-Group Trial to Assess the Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.
In the previously conducted Phase III clinical trials, Cycloset® (up to a maximum dose of
4.8 mg/day), administered either as monotherapy or combined with sulfonylurea therapy,
significantly reduced HbA1c, fasting and post-prandial glucose and fasting and post-prandial
triglycerides in obese individuals with type 2 diabetes mellitus. Clinical studies that
combined Cycloset® with metformin were not as part of the original Cycloset® clinical
program because metformin was not commercially available in the United States at the time
that the studies were initiated. The present study is designed to investigate the efficacy
and safety of Cycloset® compared to placebo when added to metformin monotherapy in persons
with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.
A sufficient number of individuals will be screened to enroll up to 326
subjects;approximately 276 subjects are expected to complete treatment through study
termination (Week 26). The study population will consist of individuals currently treated
with metformin, for at least 3 months prior to the study start. Subjects who have ever
received exogenous insulin therapy as part of an outpatient diabetes treatment regimen are
to be excluded, as are those taking oral anti-diabetic agents other than metformin within 3
months of screening (e.g., sulfonylureas, thiazolidinediones,alpha-glucosidase inhibitors,
or meglitinides). Subjects may be male or female(surgically sterile, postmenopausal, or
using appropriate contraceptive methods if of childbearing potential), age 18 to 75 years,
inclusive, and are to have a screening HbA1c value of ≥ 7.5% and <11.0% and a screening body
mass index (BMI) in the range of 25 kg/m2 to 42 kg/m2, inclusive.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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