Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin
Primary Purpose
Type 2 Diabetes
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bromocriptine Mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, diabetes mellitus
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bromocriptine Mesylate
Placebo
Arm Description
Bromocriptine mesylate 0.8 mg
Bromocriptine mesylate 0.8 mg matching placebo
Outcomes
Primary Outcome Measures
Change in Baseline to End of Study in HbA1c
Too few subjects were enrolled to assess outcome to pre-specified statistical power.
Secondary Outcome Measures
Fasting Plasma Glucose and Lipids
Number of Serious Adverse Events Experienced by the Subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00441363
Brief Title
Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Failure to Recruit in a Timely manner
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VeroScience
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
diabetes, diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bromocriptine Mesylate
Arm Type
Active Comparator
Arm Description
Bromocriptine mesylate 0.8 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Bromocriptine mesylate 0.8 mg matching placebo
Intervention Type
Drug
Intervention Name(s)
Bromocriptine Mesylate
Other Intervention Name(s)
Cycloset
Intervention Description
0.8 mg tablet
Primary Outcome Measure Information:
Title
Change in Baseline to End of Study in HbA1c
Description
Too few subjects were enrolled to assess outcome to pre-specified statistical power.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Fasting Plasma Glucose and Lipids
Time Frame
up to 24 weeks
Title
Number of Serious Adverse Events Experienced by the Subjects
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E Scranton, MD
Organizational Affiliation
VeroScience
Official's Role
Study Director
12. IPD Sharing Statement
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Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin
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