Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin

NCT00441363 | Terminated Phase 3 Results

• 1 other identifier: 165-AD-04-03-US-2
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Baseline to End of Study in HbA1c

  Too few subjects were enrolled to assess outcome to pre-specified statistical power.

  up to 24 weeks

Secondary Outcomes (2)

• Fasting Plasma Glucose and Lipids

  up to 24 weeks

• Number of Serious Adverse Events Experienced by the Subjects

  up to 24 weeks

Study Arms (2)

Bromocriptine Mesylate

ACTIVE COMPARATOR

Bromocriptine mesylate 0.8 mg

Drug: Bromocriptine Mesylate

Placebo

PLACEBO COMPARATOR

Bromocriptine mesylate 0.8 mg matching placebo

Drug: Bromocriptine Mesylate

Interventions

Bromocriptine Mesylate DRUG

0.8 mg tablet

Also known as: Cycloset

Bromocriptine Mesylate; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus, for at least six months prior to screening.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VeroScience: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Donna Cowan
• Organization: VeroScience

donna_cowan@veroscience.com

401 816-0525

Study Officials

• Richard E Scranton, MD

  VeroScience

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: February 28, 2007
• Study Start: February 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: March 1, 2006
• Last Updated: May 9, 2016
• Results First Posted: May 9, 2016

Record last verified: 2016-04