Status:
TERMINATED
Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin
Lead Sponsor:
VeroScience
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 mg/day for 3 months prior to screening) in persons with ...
Detailed Description
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 H...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes mellitus, for at least six months prior to screening.
- 18-75 years of age, inclusive.
- Male or if female, is either:
- postmenopausal or
- of childbearing potential and has used appropriate contraceptive methods
- Treated with a stable dose of metformin at least 3 months.
- Has not been treated with a sulfonylurea, thiazolidinedione, meglitinide, alpha-glucosidase inhibitor, or combination oral anti-diabetic therapy within 3 months prior to screening.
- Has not been on a regimen of lipid-lowering agents or if on such a regimen, it has been stable for a minimum of 6 weeks at screening.
- HbA1c value between ≥ 7.5% and \< 11%, at screening (Visit 1) and Visit 3.
- Fasting plasma glucose measurement of ≤260 mg/dL at screening (Visit 1) and Visit 3.
- Fasting C-peptide value equal to or greater than the normal accepted minimum value (e.g. \< 0.9 NG/ml).
- Stable body weight, i.e., not varying by \> 10% for at least3 months prior to screening
- Body mass index (BMI) at screening of 25 kg/m2 to 42 kg/m2,inclusive.
- If treated for hypertension, the individual has been on stable therapy for 1 month prior to screening.
Exclusion
- Prior exogenous insulin therapy as part of an outpatient diabetes treatment regimen.
- Type 1 diabetes mellitus
- Clinically significant history of cardiac disease or presence of cardiac disease, including MI, clinically significant arrhythmia, unstable angina pectoris, moderate to severe congestive heart failure, CABG, or angioplasty; or expected to require CABG or angioplasty during the study.
- 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:
- Hepatic disease (i.e. impaired liver function, including having AST or ALT greater than three times the upper limit of normal)
- Renal disease (i.e. renal impairment with a serum creatinine ≥ 1.4 mg/dl)
- Central nervous system disease, including epilepsy
- CVA within the last 3 years.
- Less than 5 years remission from clinically significant malignancy.
- Major surgical operation within 3 months of screening.
- Organ transplantation.
- Evidence of acute or chronic illness including known or suspected HIV,HBV, or HCV infection.
- Currently abuses drugs or alcohol, including binge drinking, or history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
- Regularly uses medications with addictive potential such as opiates,narcotics, tranquilizers, etc.
- Used drugs for weight loss, e.g., Xenical® (orlistat), Meridia® (sibutramine),Acutrim® (phenylpropanolamine), or similar over-the-counter medications within 3 months of screening.
- Known hypersensitivity to any components of the study drugs.
- Received any experimental drug or used an experimental device within 3 months of screening or will do so during the study.
- Has received unstable dose of fibric acid derivatives within 3 months of the screening.
- Requires regular use of systemic corticosteroids by oral, intravenous (IV),or intramuscular (IM) route, or regular use of potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption.
- Prescription sympathomimetic drugs within 7 days of screening.
- Started therapy with an erectile dysfunction drug within 2 weeks prior to screening. The subject may not begin treatment with an erectile dysfunction drug during the study period; subjects previously taking erectile dysfunction drugs should do so only under medical supervision.
- Donated blood within 60 days of screening. Donation of blood also is prohibited during the study and for 30 days after completion of the study.
- Occupation that requires a rotation of shift work or working over night shifts.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00441363
Start Date
February 1 2005
End Date
March 1 2006
Last Update
May 9 2016
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