Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441363
Status:
TERMINATED
Last Update Posted:
2016-05-09
First Post:
2007-02-27
Brief Title:
Efficacy and Safety of Cycloset Compared With Placebo When Added to Metformin
Sponsor:
VeroScience
Organization:
VeroScience
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to Recruit in a Timely manner
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the efficacy and safety of Cycloset and placebo when added to metformin monotherapy at least 1000 mgday for 3 months prior to screening in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone
Detailed Description:
In the previously conducted Phase III clinical trials Cycloset up to a maximum dose of 48 mgday 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 subjectsapproximately 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 eg sulfonylureas thiazolidinedionesalpha-glucosidase inhibitors or meglitinides Subjects may be male or femalesurgically 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 75 and 110 and a screening body mass index BMI in the range of 25 kgm2 to 42 kgm2 inclusive
A sufficient number of individuals will be screened to enroll up to 326 subjectsapproximately 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 eg sulfonylureas thiazolidinedionesalpha-glucosidase inhibitors or meglitinides Subjects may be male or femalesurgically 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 75 and 110 and a screening body mass index BMI in the range of 25 kgm2 to 42 kgm2 inclusive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None