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Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377676
First Posted: September 18, 2006
Last Update Posted: June 10, 2016
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.
Information provided by (Responsible Party):
VeroScience
Results First Submitted: November 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Cycloset
Drug: Usual Diabetes Therapy plus placebo

  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
Patients were recruited from 74 centers across the United States and Puerto Rico, including 19 Veterans Affairs (VA) hospitals. First patient enrolled: 23 August 2004 Last patient completed: 25 January 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4,074 subjects were screened, 3,095 randomized 2:1 to Cycloset or placebo. 3,095 were analyzed for safety and 3,070 for all other analyses.The most common reason given for screen failure due to protocol ineligibility was an elevated creatinine (24.7% of all screen failures).

Reporting Groups
  Description
Cycloset During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
Placebo During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.

Participant Flow:   Overall Study
    Cycloset   Placebo
STARTED   2054 [1]   1016 
COMPLETED   1093   694 
NOT COMPLETED   961   322 
Adverse Event                498                107 
Protocol Violation                33                27 
Death                5                2 
Withdrawal by Subject                187                72 
Lost to Follow-up                120                56 
not specified                118                58 
[1] 25 subjects did not receive study drug - thus 3070 were randomized and received drug



  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 During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
Placebo During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
Total Total of all reporting groups

Baseline Measures
   Cycloset   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2054   1016   3070 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   1453   701   2154 
>=65 years   601   315   916 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (10)   59.5  (10)   59.7  (10) 
Gender 
[Units: Participants]
     
Female   913   418   1331 
Male   1141   598   1739 
Region of Enrollment 
[Units: Participants]
     
United States   2054   1016   3070 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjects Experiencing Serious Adverse Events   [ Time Frame: From baseline to week 52. ]

2.  Secondary:   Number of Subjects Experiencing Serious Cardiovascular Adverse Events   [ Time Frame: Baseline to week 52. ]

3.  Secondary:   Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea   [ Time Frame: Baseline to week 24 ]

4.  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.   [ Time Frame: Baseline to week 24 ]


  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
Thus HbA1c was only performed on a subset of patients defined as failing (HbA1c >= 7.5) and who were on oral diabetes medications. Forced titration of study drug may have lead to a greater number of discontinuations.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Richard Scranton
Organization: VeroScience
phone: 401 816-0525
e-mail: richard_scranton@veroscience.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VeroScience
ClinicalTrials.gov Identifier: NCT00377676     History of Changes
Other Study ID Numbers: 165-AD-04-03-US-1
First Submitted: September 14, 2006
First Posted: September 18, 2006
Results First Submitted: November 8, 2010
Results First Posted: October 28, 2011
Last Update Posted: June 10, 2016