Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377676
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2006-09-14
Brief Title:
Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes
Sponsor:
VeroScience
Organization:
VeroScience
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial to Assess Safety and Tolerability During Treatment of Type 2 Diabetes T2DM With Usual Diabetes Therapy UDT and Either Cycloset or Placebo
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cycloset a new quick-release oral formulation of bromocriptine mesylate effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central hypothalamic circadian organization of monoamine neuronal activities
The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes any potential positive cardiovascular benefits will be evaluated as well
The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes any potential positive cardiovascular benefits will be evaluated as well
Detailed Description:
Bromocriptine mesylate an ergot derivative is a sympatholytic dopamine D2 receptor agonist that can exert inhibitory effects on serotonin turnover in the central nervous system It has been proposed that bromocriptine can reverse many of the metabolic alterations associated with insulin resistance and obesity by resetting central hypothalamic circadian organization of monoamine neuronal activities
While Cycloset has demonstrated efficacy by reducing HbA1c fasting and post-prandial glucose and fasting and post-prandial triglycerides the relatively small numbers of individuals treated for type 2 diabetes during the controlled Phase III clinical trials of Cycloset did not allow for a full evaluation of the safety profile Since persons with diabetes are already at higher risk for cardiovascular disease it is important to examine more fully the spectrum of potential adverse or positive effects from Cycloset in a large sample of persons with diabetes Accordingly the present study is designed to investigate the clinical safety of treatment with Cycloset in a broad population of persons with type 2 diabetes
To determine in subjects with type 2 diabetes mellitus receiving Usual Diabetes Therapy UDT consisting of either diet oral hypoglycemic agents OHA no more than 2 or insulin with or without no more than 1 OHA plus either Placebo or Cycloset
1 Whether add-on therapy with Cycloset results in all-cause rate of serious adverse events which are not higher than add-on therapy with Placebo
2 Whether add-on therapy with Cycloset results in disease-specific rate of serious cardiovascular adverse events which are not higher than add-on therapy with Placebo
While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes any potential positive cardiovascular benefits will be evaluated as well
Other clinical measures
3 The impact either positive or negative of Cycloset on HbA1c fasting plasma glucose weight triglycerides lipids blood pressure and patient tolerability after 12 months of therapy
Furthermore Hba1c changes from baseline to 24 weeks between Cycloset and Placebo among subjects with a baseline Hba1c of 75 among the following subgroups
A Treated at baseline with any Oral hypoglycemic agent OHA including injectable insulin secretagogues B Metformin plus or minus one OHA or injectable insulin secretagogue C Sulphonylurea plus or minus one OHA or injectable insulin secretagogue D Treated at baseline with Metformin and one sulphonylurea
While Cycloset has demonstrated efficacy by reducing HbA1c fasting and post-prandial glucose and fasting and post-prandial triglycerides the relatively small numbers of individuals treated for type 2 diabetes during the controlled Phase III clinical trials of Cycloset did not allow for a full evaluation of the safety profile Since persons with diabetes are already at higher risk for cardiovascular disease it is important to examine more fully the spectrum of potential adverse or positive effects from Cycloset in a large sample of persons with diabetes Accordingly the present study is designed to investigate the clinical safety of treatment with Cycloset in a broad population of persons with type 2 diabetes
To determine in subjects with type 2 diabetes mellitus receiving Usual Diabetes Therapy UDT consisting of either diet oral hypoglycemic agents OHA no more than 2 or insulin with or without no more than 1 OHA plus either Placebo or Cycloset
1 Whether add-on therapy with Cycloset results in all-cause rate of serious adverse events which are not higher than add-on therapy with Placebo
2 Whether add-on therapy with Cycloset results in disease-specific rate of serious cardiovascular adverse events which are not higher than add-on therapy with Placebo
While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes any potential positive cardiovascular benefits will be evaluated as well
Other clinical measures
3 The impact either positive or negative of Cycloset on HbA1c fasting plasma glucose weight triglycerides lipids blood pressure and patient tolerability after 12 months of therapy
Furthermore Hba1c changes from baseline to 24 weeks between Cycloset and Placebo among subjects with a baseline Hba1c of 75 among the following subgroups
A Treated at baseline with any Oral hypoglycemic agent OHA including injectable insulin secretagogues B Metformin plus or minus one OHA or injectable insulin secretagogue C Sulphonylurea plus or minus one OHA or injectable insulin secretagogue D Treated at baseline with Metformin and one sulphonylurea
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