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

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ClinicalTrials.gov Identifier: NCT01318070
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : July 6, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

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: Alogliptin and pioglitazone
Drug: Pioglitazone

  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 33 investigative sites in Japan from 22 November 2007 to 22 October 2008.

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

Reporting Groups
  Description
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 mg or 30 mg QD Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.

Participant Flow:   Overall Study
    Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD   Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD   Pioglitazone 15 mg or 30 mg QD
STARTED   111   113   115 
COMPLETED   109   111   108 
NOT COMPLETED   2   2   7 
Adverse Event                1                1                5 
Withdrawal by Subject                0                1                1 
Lack of Efficacy                0                0                1 
Principal Investigator Discretion                1                0                0 



  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 Pioglitazone 15 or 30mg QD Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Pioglitazone 15 mg or 30 mg QD Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD   Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD   Pioglitazone 15 mg or 30 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   113   115   339 
Age, Customized 
[Units: Participants]
       
≤ 64 years   77   70   77   224 
≥ 65 years   34   43   38   115 
Gender 
[Units: Participants]
       
Female   44   43   39   126 
Male   67   70   76   213 


  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

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

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



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01318070     History of Changes
Other Study ID Numbers: SYR-322/CCT-004
UMIN000001382 ( Registry Identifier: UMIN-CTR )
JapicCTI-080590 ( Registry Identifier: JapicCTI )
U1111-1118-4073 ( Registry Identifier: WHO )
First Submitted: March 16, 2011
First Posted: March 18, 2011
Results First Submitted: June 8, 2011
Results First Posted: July 6, 2011
Last Update Posted: February 3, 2012