Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )

ClinicalTrials.gov Identifier:

NCT01263470

First received: December 17, 2010

Last updated: February 1, 2012

Last verified: February 2012

History of Changes

Results First Received: June 8, 2011

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: Voglibose Drug: 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 enrolled at 54 investigative sites in Japan from 17 January 2007 to 22 December 2007.

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 with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 6, once-daily (QD) or three-times daily (TID) treatment groups.

Reporting Groups

	Description
Placebo	Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Alogliptin 6.25 mg QD	Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg QD	Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Voglibose 0.2 mg TID	Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.

Participant Flow: Overall Study

	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
STARTED	75	79	84	80	79	83
COMPLETED	73	74	80	77	76	78
NOT COMPLETED	2	5	4	3	3	5
Adverse Event	2	2	1	1	2	2
Protocol Violation	0	1	0	0	0	1
Withdrawal by Subject	0	1	1	2	0	2
Lack of Efficacy	0	0	2	0	0	0
Participant Unavailability	0	1	0	0	0	0
Study Drug Non-compliance	0	0	0	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Alogliptin 6.25 mg QD	Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 12.5 mg QD	Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg QD	Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg QD	Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Voglibose 0.2 mg TID	Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID	Total
Number of Participants [units: participants]	75	79	84	80	79	83	480
Age, Customized [units: participants]
≤ 64 years	48	58	56	52	54	51	319
≥ 65 years	27	21	28	28	25	32	161
Gender [units: participants]
Female	19	23	25	17	24	27	135
Male	56	56	59	63	55	56	345

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 2). [ Time Frame: Baseline and Week 2 ]

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6. Secondary:

Change From Baseline in Fasting Plasma Glucose (Week 4). [ Time Frame: Baseline and Week 4. ]

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

Change From Baseline in Fasting C-peptide (Week 2). [ Time Frame: Baseline and Week 2. ]

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10. Secondary:

Change From Baseline in Fasting C-peptide (Week 4). [ Time Frame: Baseline and Week 4. ]

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11. Secondary:

Change From Baseline in Fasting C-peptide (Week 8). [ Time Frame: Baseline and Week 8. ]

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12. Secondary:

Change From Baseline in Fasting C-peptide (Week 12). [ Time Frame: Baseline and Week 12. ]

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13. Secondary:

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). [ Time Frame: Baseline and Week 12. ]

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14. Secondary:

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)). [ Time Frame: Baseline and Week 12. ]

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15. Secondary:

Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)). [ Time Frame: Baseline and Week 12 ]

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16. Secondary:

Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). [ Time Frame: Baseline and Week 12. ]

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17. Secondary:

Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). [ Time Frame: Baseline and Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.

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.

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

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:	NCT01263470 History of Changes
Other Study ID Numbers:	SYR-322/CCT-001, U1111-1118-3752
Study First Received:	December 17, 2010
Results First Received:	June 8, 2011
Last Updated:	February 1, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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