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

History of Changes

Results First Received: February 17, 2013

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

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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 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

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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]

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

440

≥65 years

Gender
[Units: Participants]

Female

231

Male

275

Race/Ethnicity, Customized
[Units: Participants]

506

Region of Enrollment
[Units: Participants]

Taiwan

Hong Kong

China

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%

270

≥8.0%

236

Stable Daily Dose of Metformin ^[1] [2]
[Units: Mg]
Mean (Standard Deviation)

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]

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. ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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 ]

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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

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Other Adverse Events

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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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