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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441363
Recruitment Status : Terminated (Failure to Recruit in a Timely manner)
First Posted : February 28, 2007
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Intervention: Drug: Bromocriptine Mesylate

  Participant Flow

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
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

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
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 
[Units: Years]
Mean (Standard Deviation)
 54  (10.5)   53  (9.3)   53  (9.8) 
[Units: Participants]
Female   15   14   29 
Male   17   20   37 
Region of Enrollment 
[Units: Participants]
United States   32   34   66 

  Outcome Measures

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.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
No text entered.

  More Information

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

Responsible Party: VeroScience Identifier: NCT00441363     History of Changes
Other Study ID Numbers: 165-AD-04-03-US-2
First Submitted: February 27, 2007
First Posted: February 28, 2007
Results First Submitted: November 8, 2010
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016