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Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01289119
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : March 22, 2013
Last Update Posted : March 22, 2013
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: Diabetes Mellitus, Type 2
Interventions: Drug: Alogliptin
Drug: Placebo to alogliptin
Drug: Metformin
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 took part in the study at 30 investigative sites in China, Taiwan province and Hong Kong from 23 December 2010 to 19 December 2011.

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 who were experiencing inadequate glycemic control were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.

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.

Participant Flow:   Overall Study
    Placebo   Alogliptin Monotherapy   Metformin   Metformin + Alogliptin Add-on Therapy   Pioglitazone   Pioglitazone + Alogliptin Add-on Therapy
STARTED   93   92   98   99   63   61 
Treated   92 [1]   92   98   99   63   61 
COMPLETED   84   83   89   93   58   57 
NOT COMPLETED   9   9   9   6   5   4 
Adverse Event                2                1                0                2                1                0 
Major Protocol Deviation                2                1                3                0                2                1 
Lost to Follow-up                0                3                0                0                0                1 
Withdrawal by Subject                4                2                4                3                1                1 
Pregnancy                0                1                0                0                0                0 
Lack of Efficacy                0                1                1                1                1                1 
Other                1                0                1                0                0                0 
[1] Patients who took at least one dose of double-blind study drug.



  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
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

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

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

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

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

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

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

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

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

Measure Type Secondary
Measure Title Percentage of Participants With HbA1c ≤7.5% at Week 16
Measure Description Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.
Time Frame Week 16  

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.
The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.

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.

Measured Values
   Placebo   Alogliptin Monotherapy   Metformin   Metformin + Alogliptin Add-on Therapy   Pioglitazone   Pioglitazone + Alogliptin Add-on Therapy 
Participants Analyzed 
[Units: Participants]
 		 90   90   97   98   63   60 
Percentage of Participants With HbA1c ≤7.5% at Week 16 
[Units: Percentage of participants]
 		 53.3   81.1   50.5   80.6   47.6   85.0 

No statistical analysis provided for Percentage of Participants With HbA1c ≤7.5% at Week 16



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

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

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

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