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Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

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ClinicalTrials.gov Identifier: NCT01318122
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : September 2, 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: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Intervention: Drug: Alogliptin and 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 32 investigative sites in Japan from 10 May 2008 to 03 August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had completed the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070) were enrolled in one of 2, once-daily (QD) treatment groups.

Reporting Groups
  Description
CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group

Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group

Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

Pioglitazone Monotherapy Group* → 12.5 mg Combination Group

Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.

Pioglitazone Monotherapy Group* → 25 mg Combination Group

Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.


Participant Flow for 2 periods

Period 1:   Enrolled - Long-Term Extension Study
    CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group   CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group   Pioglitazone Monotherapy Group* → 12.5 mg Combination Group   Pioglitazone Monotherapy Group* → 25 mg Combination Group
STARTED   106 [1]   110 [1]   57   53 
COMPLETED   105   110   55   52 
NOT COMPLETED   1   0   2   1 
Adverse Event                0                0                2                1 
Other                1                0                0                0 
[1] 5 randomized participants from alogliptin 12.5 & 25 mg group CCT-004 study did not enter this study

Period 2:   Entered - Long-Term Extension Study
    CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group   CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group   Pioglitazone Monotherapy Group* → 12.5 mg Combination Group   Pioglitazone Monotherapy Group* → 25 mg Combination Group
STARTED   105   110   55   52 
COMPLETED   96   99   49   48 
NOT COMPLETED   9   11   6   4 
Adverse Event                6                6                2                4 
Lost to Follow-up                1                0                0                0 
Withdrawal by Subject                2                3                1                0 
Lack of Efficacy                0                2                3                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 30 mg QD Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Total Total of all reporting groups

Baseline Measures
   Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD   Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 166   165   331 
Age, Customized 
[Units: Participants]
     
≤ 64 years   116   103   219 
≥ 65 years   50   62   112 
Gender 
[Units: Participants]
     
Female   65   58   123 
Male   101   107   208 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events.   [ Time Frame: 52 Weeks. ]

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

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

4.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 16).   [ Time Frame: Baseline and Week 16. ]

5.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 20).   [ Time Frame: Baseline and Week 20. ]

6.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 24).   [ Time Frame: Baseline and Week 24. ]

7.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 28).   [ Time Frame: Baseline and Week 28. ]

8.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 32).   [ Time Frame: Baseline and Week 32. ]

9.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 36).   [ Time Frame: Baseline and Week 36. ]

10.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 40).   [ Time Frame: Baseline and Week 40. ]

11.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 44).   [ Time Frame: Baseline and Week 44. ]

12.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 48).   [ Time Frame: Baseline and Week 48. ]

13.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 52).   [ Time Frame: Baseline and Week 52. ]

14.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Final Visit).   [ Time Frame: Baseline and Final Visit (up to Week 52). ]

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

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

17.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 16).   [ Time Frame: Baseline and Week 16. ]

18.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 20).   [ Time Frame: Baseline and Week 20. ]

19.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 24).   [ Time Frame: Baseline and Week 24. ]

20.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 28).   [ Time Frame: Baseline and Week 28. ]

21.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 32).   [ Time Frame: Baseline and Week 32. ]

22.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 36).   [ Time Frame: Baseline and Week 36. ]

23.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 40).   [ Time Frame: Baseline and Week 40. ]

24.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 44).   [ Time Frame: Baseline and Week 44. ]

25.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 48).   [ Time Frame: Baseline and Week 48. ]

26.  Secondary:   Change From Baseline in Fasting Blood Glucose (Week 52).   [ Time Frame: Baseline and Week 52. ]

27.  Secondary:   Change From Baseline in Fasting Blood Glucose (Final Visit).   [ Time Frame: Baseline and Final Visit (up to Week 52). ]

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

29.  Secondary:   Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).   [ Time Frame: Baseline and Week 24. ]

30.  Secondary:   Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).   [ Time Frame: Baseline and Week 52. ]

31.  Secondary:   Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).   [ Time Frame: Baseline and Final Visit (up to Week 52). ]


  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
331 participants were randomized in the core phase 2/3 thiazolidine (CCT-004) study and included in the Full Analysis Set in this study. 5 participants from CCT-004 study did not enter this study.


  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: NCT01318122     History of Changes
Other Study ID Numbers: SYR-322/OCT-004
U1111-1119-6207 ( Registry Identifier: WHO )
First Submitted: March 16, 2011
First Posted: March 18, 2011
Results First Submitted: June 8, 2011
Results First Posted: September 2, 2011
Last Update Posted: February 3, 2012