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Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01890122
First received: June 26, 2013
Last updated: October 4, 2016
Last verified: October 2016
Results First Received: October 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Alogliptin
Drug: Metformin HCl
Drug: Alogliptin and Metformin Fixed-Dose Combination (FDC)
Drug: Alogliptin Placebo
Drug: Metformin Placebo
Drug: Alogliptin and Metformin FDC Placebo

  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
Participants took part in the study at 59 investigative sites in China, Malaysia, South Korea and Taiwan from 26 August 2013 to 05 October 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of type 2 diabetes mellitus were enrolled equally in 1 of 4 treatment groups, twice a day placebo, alogliptin 12.5 mg, metformin hydrochloride (HCl) 500 mg, or alogliptin 12.5 mg and metformin HCl 500 mg fixed dose combination (FDC).

Reporting Groups
  Description
Metformin HCl 500 mg Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
Alogliptin 12.5 mg Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
Alogliptin 12.5 mg + Metformin HCl 500 mg FDC Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
Placebo Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Participant Flow:   Overall Study
    Metformin HCl 500 mg   Alogliptin 12.5 mg   Alogliptin 12.5 mg + Metformin HCl 500 mg FDC   Placebo
STARTED   162 [1]   163   159   163 
Treated   161 [2]   162   159   163 
COMPLETED   135   126   146   104 
NOT COMPLETED   27   37   13   59 
Adverse Event                1                1                1                2 
Major Protocol Deviation                3                1                0                1 
Lost to Follow-up                0                1                2                2 
Voluntary Withdrawal                8                8                2                11 
Lack of Efficacy                14                24                7                41 
Reason not Specified                0                1                1                2 
Randomized but not Treated                1                1                0                0 
[1] Started = Enrolled set which included all participants who signed informed consent.
[2] Treated = Randomized participants who received at least one dose of study drug.



  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.
Randomized set consisted of all enrolled participants who were randomized.

Reporting Groups
  Description
Metformin HCl 500 mg Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
Alogliptin 12.5 mg Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
Alogliptin 12.5 mg + Metformin HCl 500 mg FDC Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
Placebo Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
Total Total of all reporting groups

Baseline Measures
   Metformin HCl 500 mg   Alogliptin 12.5 mg   Alogliptin 12.5 mg + Metformin HCl 500 mg FDC   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 162   163   159   163   647 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.6  (9.91)   55.4  (9.62)   53.4  (10.46)   52.2  (10.17)   53.6  (10.08) 
Gender 
[Units: Participants]
         
Female   80   65   68   68   281 
Male   82   98   91   95   366 
Race/Ethnicity, Customized 
[Units: Participants]
         
American Indian or Alaskan Native   0   1   0   2   3 
Asian   161   162   159   161   643 
Multiracial   1   0   0   0   1 
Race/Ethnicity, Customized 
[Units: Participants]
         
Hispanic or Latino (Yes)   0   0   1   0   1 
Hispanic or Latino (No)   162   163   158   163   646 
Height 
[Units: Cm]
Mean (Standard Deviation)
 163.8  (8.72)   165.0  (8.06)   164.3  (7.66)   164.2  (9.19)   164.3  (8.42) 
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 70.79  (12.357)   71.21  (11.669)   70.73  (11.489)   71.79  (13.949)   71.13  (12.388) 
[1] Weight data is available for 161, 163, 159 and 163 participants in each treatment arm, respectively.
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.30  (3.566)   26.16  (3.923)   26.16  (3.508)   26.56  (4.218)   26.30  (3.811) 
Smoking Classification 
[Units: Participants]
         
Has Never Smoked   125   112   113   112   462 
Is a Current Smoker   27   35   38   36   136 
Is an Ex-smoker   10   16   8   15   49 
Female Reproductive Status 
[Units: Participants]
         
Postmenopausal   47   45   37   45   174 
Surgically Sterile   8   8   10   5   31 
Female of Childbearing Potential   25   12   21   18   76 
Not Applicable (Participant is Male)   82   98   91   95   366 
Region of Enrollment 
[Units: Participants]
         
China   129   129   128   130   516 
Korea, Republic of   9   10   10   10   39 
Malaysia   19   19   18   19   75 
Taiwan, Province of China   5   5   3   4   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)   [ Time Frame: Baseline and Week 26 (or Early termination) ]

2.  Secondary:   Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20   [ Time Frame: Baseline and Weeks 4, 8, 12, 16 and 20 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26 ]

4.  Secondary:   Time to Hyperglycemic Rescue Event   [ Time Frame: From the date of randomization through Week 26 ]

5.  Secondary:   Percentage of Participants Requiring Hyperglycemic Rescue   [ Time Frame: Baseline up to Week 26 ]

6.  Secondary:   Percentage of Participants With Marked Hyperglycemia   [ Time Frame: Baseline up to Week 26 ]

7.  Secondary:   Change From Baseline in Body Weight at Weeks 12 and 26   [ Time Frame: Baseline and Weeks 12 and 26 ]

8.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤6.5%   [ Time Frame: Week 26 ]

9.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤7.0%   [ Time Frame: Week 26 ]

10.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤7.5%   [ Time Frame: Week 26 ]

11.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%   [ Time Frame: Baseline and Week 26 ]

12.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%   [ Time Frame: Baseline and Week 26 ]

13.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%   [ Time Frame: Baseline and Week 26 ]

14.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%   [ Time Frame: Baseline and Week 26 ]


  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 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: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01890122     History of Changes
Other Study ID Numbers: SYR-322MET_303
U1111-1139-0497 ( Registry Identifier: WHO )
NMRR-12-799-12754 ( Registry Identifier: NMRR )
CTR20130254 ( Registry Identifier: SFDA CTR )
1036022140 ( Registry Identifier: TCTIN )
Study First Received: June 26, 2013
Results First Received: October 4, 2016
Last Updated: October 4, 2016
Health Authority: Malaysia: Ministry of Health
South Korea: Institutional Review Board
China: Food and Drug Administration
China: Ethics Committee
China: Ministry of Health
Taiwan: Food and Drug Administration, Ministry of Health and Welfare