Phase 3
Completed N=3,070
Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes
Source: ClinicalTrials.gov NCT00377676 ↗Enrolled (actual)
3,070
Serious AEs
8.9%
Results posted
Oct 2011
Primary outcomePrimary: Subjects Experiencing Serious Adverse Events — 176; 98 participants — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Experiencing Serious Adverse Events |
176; 98 | <0.05 sig |
| SECONDARY Number of Subjects Experiencing Serious Cardiovascular Adverse Events |
31; 30 | <0.05 sig |
| SECONDARY Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea |
-0.49; -0.04 | <0.001 sig |
| SECONDARY Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline. |
-0.41; 0.041 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- age 30-80 years
- body mass index 160 or diastolic BP > 100 at screening)
- coronary artery bypass graft or coronary angioplasty in the previous 3 months, myocardial infarction in the previous 6 months, or unstable angina pectoris (chest pain at rest, worsening chest pain, or admission to the ER or hospital for chest pain) within the previous 3 months
- congestive heart failure defined by NYHA as Class III or IV
- clinical nephrotic syndrome, or renal impairment with a serum creatinine > 1.4 mg/dl if female receiving treatment with metformin, > 1.5 mg/dl if male receiving treatment with metformin, and > 1.6 mg/dl in not on metformin
- impaired liver function, including having AST or ALT greater than three times the upper limit of normal
- active infection (e.g., HIV, hepatitis), or a history of severe infection during the 30 days prior to screening
- major surgical operation during the 30 days prior to screening
- cancer, other than non-melanoma skin or non metastatic prostate cancer within the past 5 years
- Any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen
- Working rotating, varying or night shifts
- Patients taking unapproved herbal supplements that may be associated with a risk of cardiovascular events (such as ephedra, yohimbe etc)
- Patients who had started therapy with an erectile dysfunction drug within 2 weeks prior to screening; patients could not begin treatment with an erectile dysfunction drug during the study period; patients previously taking erectile dysfunction drugs could do so only under medical supervision.
- Subjects with circumstances or abnormalities (e.g., blindness or a history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.
- Clinically significant abnormalities (values outside the normal range) on screening central laboratory evaluation unless discussed with and approved by the study principal investigator or Sponsor medical monitor.
Data sourced from ClinicalTrials.gov (NCT00377676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.