Long-term Study of KAD-1229 in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01333592
First received: April 6, 2011
Last updated: November 27, 2014
Last verified: November 2014
Results First Received: November 17, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Intervention: Drug: KAD-1229

  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
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Reporting Groups
  Description
KAD-1229 / DPP-4 Inhibitors No text entered.
KAD-1229 / Biguanides No text entered.

Participant Flow:   Overall Study
    KAD-1229 / DPP-4 Inhibitors     KAD-1229 / Biguanides  
STARTED     67     69  
COMPLETED     58     52  
NOT COMPLETED     9     17  



  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.
One patient in the KAD-1229 / biguanides group was excluded because of early discontinuation and no evaluable HbA1c.

Reporting Groups
  Description
KAD-1229 / DPP-4 Inhibitors No text entered.
KAD-1229 / Biguanides No text entered.
Total Total of all reporting groups

Baseline Measures
    KAD-1229 / DPP-4 Inhibitors     KAD-1229 / Biguanides     Total  
Number of Participants  
[units: participants]
  67     68     135  
Age  
[units: years]
Mean ± Standard Deviation
  60.3  ± 10.6     56.9  ± 11.5     58.6  ± 11.1  
Gender  
[units: participants]
     
Female     21     18     39  
Male     46     50     96  
HbA1c  
[units: %]
Mean ± Standard Deviation
  7.47  ± 0.54     7.50  ± 0.66     7.49  ± 0.60  



  Outcome Measures
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1.  Primary:   Incidences of Adverse Events   [ Time Frame: 52 weeks ]

2.  Secondary:   Change From Baseline in HbA1c at 52 Weeks   [ Time Frame: at week 0 and week 52 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Clinical Development Division
Organization: Kissei Pharmaceutical Co., Ltd
e-mail: rinsyousiken@pharm.kissei.co.jp


No publications provided


ClinicalTrials.gov Identifier: NCT01333592     History of Changes
Other Study ID Numbers: KAD4301
Study First Received: April 6, 2011
Results First Received: November 17, 2014
Last Updated: November 27, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare