Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
VeroScience |
---|---|
Information provided by: | VeroScience |
ClinicalTrials.gov Identifier: | NCT00441363 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: bromocriptine mesylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 326 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or if female, is either:
Exclusion Criteria:
Uncontrolled hypertension, defined as systolic blood pressure > 160 or diastolic blood pressure > 100 mmHg measured in sitting position at screening(Visit 1)
Clinically significant history or presence of:
Study ID Numbers: | 165-AD-04-03-US-2 |
Study First Received: | February 27, 2007 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00441363 |
Health Authority: | United States: Food and Drug Administration |
diabetes diabetes mellitus |
Bromocriptine Dopamine Metabolic Diseases Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Hormone Antagonists Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Antiparkinson Agents Dopamine Agents Dopamine Agonists Central Nervous System Agents Pharmacologic Actions |