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A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator

This study has been completed.
Sponsor:
Information provided by:
InteKrin Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00631007
First received: February 27, 2008
Last updated: August 18, 2010
Last verified: August 2010
History of Changes
Results First Received: August 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: INT131 besylate
Drug: Pioglitazone HCl
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 30 - 75 years of age with type 2 diabetes mellitus with inadequate glycemic control (HbA1c ≥7.5% and ≤ 10% and a Fasting Plasma Glucose <240 mg/dL) at screening on sulfonylurea monotherapy or sulfonylurea plus metformin were eligible to enter the study.

Reporting Groups
  Description
INT131 Besylate 0.5 mg INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
INT131 Besylate 1 mg INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
INT131 Besylate 2 mg INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
INT131 Besylate 3 mg INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
Pioglitazone HCl 45 mg pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
Placebo placebo administered once-daily

Participant Flow:   Overall Study
    INT131 Besylate 0.5 mg     INT131 Besylate 1 mg     INT131 Besylate 2 mg     INT131 Besylate 3 mg     Pioglitazone HCl 45 mg     Placebo  
STARTED     60     61     63     62     60     61  
COMPLETED     49     50     53     53     48     46  
NOT COMPLETED     11     11     10     9     12     15  
Adverse Event                 0                 2                 0                 2                 3                 2  
Lost to Follow-up                 2                 1                 2                 4                 5                 3  
Physician Decision                 1                 0                 1                 0                 0                 2  
Persistent Hyperglycemia                 2                 2                 5                 1                 2                 5  
Withdrawal by Subject                 4                 5                 2                 2                 1                 3  
Other                 2                 1                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
INT131 Besylate 0.5 mg INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
INT131 Besylate 1 mg INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
INT131 Besylate 2 mg INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
INT131 Besylate 3 mg INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
Pioglitazone HCl 45 mg pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
Placebo placebo administered once-daily
Total Total of all reporting groups

Baseline Measures
    INT131 Besylate 0.5 mg     INT131 Besylate 1 mg     INT131 Besylate 2 mg     INT131 Besylate 3 mg     Pioglitazone HCl 45 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  60     61     63     61     60     61     366  
Age  
[units: years]
Mean ± Standard Deviation 		  54.9  ± 8.48     58.0  ± 9.18     56.1  ± 7.98     54.8  ± 9.76     55.8  ± 10.40     55.3  ± 10.93     55.8  ± 9.50  
Gender  
[units: participants]
 		             
Female     24     29     32     25     32     28     170  
Male     36     32     31     36     28     33     196  
Ethnicity (NIH/OMB)  
[units: participants]
 		             
Hispanic or Latino     29     31     29     32     28     31     180  
Not Hispanic or Latino     31     30     34     29     32     30     186  
Race (NIH/OMB)  
[units: participants]
 		             
American Indian or Alaska Native     6     7     6     5     5     7     36  
Asian     0     0     2     1     1     0     4  
Native Hawaiian or Other Pacific Islander     1     0     0     0     1     2     4  
Black or African American     7     4     10     6     9     6     42  
White     46     50     45     49     44     46     280  
Region of Enrollment  
[units: participants]
 		             
United States     51     50     52     52     51     49     305  
Mexico     9     11     11     9     9     12     61  
Hemoglobin A1c  
[units: Percent]
Mean ± Standard Deviation 		  8.3  ± 0.76     8.3  ± 0.71     8.5  ± 0.69     8.3  ± 0.65     8.2  ± 0.67     8.4  ± 0.80     8.3  ± 0.72  



  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward   [ Time Frame: Weeks 0-24 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.   [ Time Frame: Weeks 0-24 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  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.


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.  


Results Point of Contact:  
Name/Title: Chief Executive Officer
Organization: InteKrin Therapeutics
phone: 650-941-5501
e-mail: Info@intekrin.com


No publications provided


Responsible Party: Chief Executive Officer, InteKrin Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00631007     History of Changes
Other Study ID Numbers: INT131-007
Study First Received: February 27, 2008
Results First Received: August 18, 2010
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration