Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01318109
First received: March 16, 2011
Last updated: February 1, 2012
Last verified: February 2012
Results First Received: June 8, 2011  
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: Alogliptin and metformin
Drug: Metformin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled at 30 investigative sites in Japan from 22 August 2008 to 28 April 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite treatment with metformin as well as diet and exercise were enrolled in one of 3, once-daily (QD), twice daily (BID) or three times daily (TID) treatment groups.

Reporting Groups
  Description
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Metformin 500mg BID or 750mg TID Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.

Participant Flow:   Overall Study
    Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID     Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID     Metformin 500mg BID or 750mg TID  
STARTED     92     96     100  
COMPLETED     91     93     100  
NOT COMPLETED     1     3     0  
Adverse Event                 0                 2                 0  
Withdrawal by Subject                 1                 0                 0  
Schedule Conflict                 0                 1                 0  



  Baseline Characteristics
  Hide 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
  Description
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Metformin 500mg BID or 750mg TID Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID     Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID     Metformin 500mg BID or 750mg TID     Total  
Number of Participants  
[units: participants]
  92     96     100     288  
Age  
[units: years]
Mean ± Standard Deviation
  53.4  ± 8.80     52.3  ± 8.02     52.1  ± 8.05     52.6  ± 8.28  
Gender  
[units: participants]
       
Female     32     30     28     90  
Male     60     66     72     198  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (Week 12).   [ Time Frame: Baseline and Week 12. ]

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 2).   [ Time Frame: Baseline and Week 2. ]

3.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 4).   [ Time Frame: Baseline and Week 4. ]

4.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 8).   [ Time Frame: Baseline and Week 8. ]

5.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 2).   [ Time Frame: Baseline and Week 2. ]

6.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 4).   [ Time Frame: Baseline and Week 4. ]

7.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 8).   [ Time Frame: Baseline and Week 8. ]

8.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 12).   [ Time Frame: Baseline and Week 12. ]

9.  Secondary:   Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).   [ Time Frame: Baseline and Week 12. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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: General Manager
Organization: Japan Development Center, Pharmaceutical Development Division
phone: +81-6-6204-5257
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01318109     History of Changes
Other Study ID Numbers: SYR-322/CCT-006, JapicCTI-080629, UMIN000001394, U1111-1119-6303
Study First Received: March 16, 2011
Results First Received: June 8, 2011
Last Updated: February 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare