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Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01289119
First received: February 1, 2011
Last updated: February 17, 2013
Last verified: February 2013
Results First Received: February 17, 2013  
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: Diabetes Mellitus, Type 2
Interventions: Drug: Alogliptin
Drug: Placebo to alogliptin
Drug: Metformin
Drug: Pioglitazone

  Participant Flow


  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.
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Reporting Groups
  Description
Placebo Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
Alogliptin Monotherapy Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Metformin Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Metformin + Alogliptin Add-on Therapy Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Pioglitazone Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Pioglitazone + Alogliptin Add-on Therapy Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo   Alogliptin Monotherapy   Metformin   Metformin + Alogliptin Add-on Therapy   Pioglitazone   Pioglitazone + Alogliptin Add-on Therapy   Total
Overall Participants Analyzed 
[Units: Participants]
 93   92   98   99   63   61   506 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.1  (8.88)   51.6  (10.41)   53.2  (9.46)   53.0  (9.88)   51.8  (10.37)   52.6  (9.44)   52.6  (9.71) 
Age, Customized 
[Units: Participants]
             
<65 Years   81   80   86   85   56   52   440 
≥65 years   12   12   12   14   7   9   66 
Gender 
[Units: Participants]
             
Female   39   37   50   48   24   33   231 
Male   54   55   48   51   39   28   275 
Race/Ethnicity, Customized 
[Units: Participants]
 93   92   98   99   63   61   506 
Region of Enrollment 
[Units: Participants]
             
Taiwan   1   0   2   3   0   0   6 
Hong Kong   1   2   2   4   0   0   9 
China   91   90   94   92   63   61   491 
Height 
[Units: Cm]
Mean (Standard Deviation)
 165.4  (7.19)   165.9  (8.61)   164.8  (8.47)   165.7  (9.06)   166.2  (8.87)   163.0  (7.06)   165.2  (8.31) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 70.86  (10.464)   71.16  (11.065)   69.67  (11.792)   71.20  (13.473)   72.44  (11.989)   67.59  (11.989)   70.55  (11.856) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.86  (3.002)   25.79  (3.086)   25.54  (2.876)   25.75  (3.122)   26.13  (3.031)   25.32  (3.223)   25.73  (3.042) 
Diabetes duration 
[Units: Years]
Mean (Standard Deviation)
 2.12  (2.845)   1.86  (2.369)   5.33  (3.873)   5.38  (4.335)   4.85  (4.724)   5.80  (5.300)   4.11  (4.215) 
HbA1c 
[Units: Participants]
             
<8.0%   47   48   54   55   34   32   270 
≥8.0%   46   44   44   44   29   29   236 
Stable Daily Dose of Metformin [1] [2] 
[Units: Mg]
Mean (Standard Deviation)
 NA [2]   NA [2]   1484.2  (451.09)   1472.2  (417.31)   1355.0  (431.80)   1295.0  (506.82)   1426.6  (450.90) 
[1] Participant population for this measure for each treatment arm: 0, 0, 98, 99, 50, 50; Total population: 297
[2] Participants in this arm were not taking Metformin
Stable Daily Dose of Pioglitazone [1] [2] 
[Units: Mg]
Mean (Standard Deviation)
 NA [2]   NA [2]   NA [2]   NA [2]   21.9  (11.37)   20.2  (7.19)   21.0  (9.55) 
[1] Participant population for this measure for each treatment arm: 0, 0, 0, 0, 63, 61; Total population: 124
[2] Participants in this arm were not taking Pioglitazone


  Outcome Measures
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1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline and Week 16. ]

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

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose Over Time   [ Time Frame: Baseline and Weeks 4, 8, 12 and 16. ]

4.  Secondary:   Percentage of Participants With Marked Hyperglycemia   [ Time Frame: Randomization to Week 16. ]

5.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline and Weeks 8 and 16. ]

6.  Secondary:   Percentage of Participants With HbA1c ≤6.5% at Week 16   [ Time Frame: Week 16 ]

7.  Secondary:   Percentage of Participants With HbA1c ≤7.0% at Week 16   [ Time Frame: Week 16 ]

8.  Secondary:   Percentage of Participants With HbA1c ≤7.5% at Week 16   [ Time Frame: Week 16 ]

9.  Secondary:   Percentage of Participants With a Decrease in HbA1c ≥ 0.5%   [ Time Frame: Baseline and Week 16 ]

10.  Secondary:   Percentage of Participants With a Decrease in HbA1c ≥1.0%   [ Time Frame: Baseline and Week 16 ]

11.  Secondary:   Percentage of Participants With a Decrease in HbA1c ≥1.5%   [ Time Frame: Baseline and Week 16. ]

12.  Secondary:   Percentage of Participants With a Decrease in HbA1c ≥2.0%   [ Time Frame: Baseline and Week 16. ]


  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