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START-J: SiTAgliptin in eldeRly Trial in Japan (START-J)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183104
First Posted: August 17, 2010
Last Update Posted: April 14, 2017
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Japan Association for Diabetes Education and Care
Results First Submitted: December 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Sitagliptin
Drug: Glimepiride

  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
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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
Sitagliptin Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
Glimepiride Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg

Participant Flow:   Overall Study
    Sitagliptin   Glimepiride
STARTED   153   152 
Received Study Drug [1]   148   143 
Continued Treatment for 12 Weeks [2]   143   129 
Completed 52-week Treatment   119   111 
Enrolled in Extension Study   80   61 
COMPLETED [3]   76   60 
NOT COMPLETED   77   92 
Adverse Event                8                6 
Death                0                1 
Lost to Follow-up                14                7 
Physician Decision                5                8 
Withdrawal by Subject                6                11 
Nonparticipation in Extension Study                39                50 
Did not receive study drug                5                9 
[1] Analysis set of evaluation for safety
[2] Analysis set of evaluation for efficacy; Per Protocol Set
[3] 104-week extension study



  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.
Analysis set of evaluation for efficacy ; Per Protocol Set

Reporting Groups
  Description
Sitagliptin Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
Glimepiride Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
Total Total of all reporting groups

Baseline Measures
   Sitagliptin   Glimepiride   Total 
Overall Participants Analyzed 
[Units: Participants]
 143   129   272 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.2  (5.4)   70.8  (5.5)   70.5  (5.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      69  48.3%      50  38.8%      119  43.8% 
Male      74  51.7%      79  61.2%      153  56.3% 
Region of Enrollment 
[Units: Participants]
     
Japan   143   129   272 
HbA1c 
[Units: Percent]
Mean (Standard Deviation)
 7.48  (0.68)   7.49  (0.67)   7.48  (0.67) 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.1  (3.3)   24.2  (3.6)   24.2  (3.4) 
eGFR 
[Units: mL/min/1.73m^2]
Mean (Standard Deviation)
 68.8  (17.1)   67.9  (17.1)   68.4  (17.1) 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 60.9  (9.7)   60.9  (9.7)   60.9  (9.7) 
HOMA-β 
[Units: Percent]
Mean (Standard Deviation)
 43.3  (33.7)   38.5  (34.0)   41.1  (33.9) 
Insulin/Proinsulin Ratio 
[Units: Ratio]
Mean (Standard Deviation)
 0.217  (0.122)   0.205  (0.129)   0.211  (0.125) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c at 52 W   [ Time Frame: Baseline and 52 W ]

2.  Primary:   Number of Participants With Hypoglycaemia   [ Time Frame: From baseline to 52 W ]

3.  Secondary:   The Number of Participants Achieving HbA1c < 6.9 %   [ Time Frame: 52 W ]

4.  Secondary:   Change From Baseline in HOMA-β at 52 W   [ Time Frame: Baseline and 52 W ]

5.  Secondary:   Change From Baseline in Insulin/Proinsulin Ratio at 52 W   [ Time Frame: Baseline and 52 W ]

6.  Secondary:   Change From Baseline in Body Weight at 52 W   [ Time Frame: Baseline and 52 W ]


  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: Prof. Yasuo Terauchi
Organization: Japan Association for Diabetes Education and Care
phone: +81-3-3514-1721
e-mail: terauchi-tky@umin.ac.jp



Responsible Party: Japan Association for Diabetes Education and Care
ClinicalTrials.gov Identifier: NCT01183104     History of Changes
Other Study ID Numbers: START-J
UMIN000004047 ( Other Identifier: UMIN )
First Submitted: August 16, 2010
First Posted: August 17, 2010
Results First Submitted: December 5, 2016
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017