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

This study has been terminated.
(Failure to Recruit in a Timely manner)
Sponsor:
Information provided by (Responsible Party):
VeroScience
ClinicalTrials.gov Identifier:
NCT00441363
First received: February 27, 2007
Last updated: April 26, 2016
Last verified: April 2016
Results First Received: November 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Intervention: Drug: Bromocriptine Mesylate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was originally designed to enroll 326 subjects in order to randomize 225 subjects. Due to a strategic business decision of the former sponsor (PLIVA), enrollment into the study was prematurely terminated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cycloset 0.8 mg tablet
Placebo matching placebo

Participant Flow:   Overall Study
    Cycloset   Placebo
STARTED   32   34 
COMPLETED   15 [1]   19 
NOT COMPLETED   17   15 
Adverse Event                4                2 
Withdrawal by Subject                3                4 
Physician Decision                6                7 
Lost to Follow-up                2                2 
not specified                2                0 
[1] no subject withdrew early since the trial was terminated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cycloset 0.8 mg tablet
Placebo matching placebo
Total Total of all reporting groups

Baseline Measures
   Cycloset   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   34   66 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (10.5)   53  (9.3)   53  (9.8) 
Gender 
[Units: Participants]
     
Female   15   14   29 
Male   17   20   37 
Region of Enrollment 
[Units: Participants]
     
United States   32   34   66 


  Outcome Measures
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1.  Primary:   Change in Baseline to End of Study in HbA1c   [ Time Frame: up to 24 weeks ]

2.  Secondary:   Number of Serious Adverse Events Experienced by the Subjects   [ Time Frame: up to 24 weeks ]

3.  Secondary:   Fasting Plasma Glucose and Lipids   [ Time Frame: up to 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Donna Cowan
Organization: VeroScience
phone: 401 816-0525
e-mail: donna_cowan@veroscience.com



Responsible Party: VeroScience
ClinicalTrials.gov Identifier: NCT00441363     History of Changes
Other Study ID Numbers: 165-AD-04-03-US-2
Study First Received: February 27, 2007
Results First Received: November 8, 2010
Last Updated: April 26, 2016
Health Authority: United States: Food and Drug Administration