Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takeda

ClinicalTrials.gov Identifier:

NCT00957268

First received: August 6, 2009

Last updated: January 26, 2015

Last verified: January 2015

History of Changes

Results First Received: November 21, 2014

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Parallel Assignment; Masking: Open Label
Condition:	Diabetes Mellitus, Type 2
Intervention:	Drug: Alogliptin

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 6 investigative sites in the United States from 17 Sep 2009 to 22 Nov 2013.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants aged 10 to 65 with a diagnosis of type 2 diabetes mellitus were enrolled in 1 of 5 treatment groups and received 12.5 or 25 mg alogliptin once.

Reporting Groups

	Description
Alogliptin 12.5 mg (Age 10 to < 14 Years)	Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 10 to < 14 Years)	Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 12.5 mg (Age 14 to < 18 Years)	Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 14 to < 18 Years)	Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 18 to 65 Years)	Alogliptin 25 mg QD, tablets, orally, 1 dose only.

Participant Flow: Overall Study

	Alogliptin 12.5 mg (Age 10 to < 14 Years)	Alogliptin 25 mg (Age 10 to < 14 Years)	Alogliptin 12.5 mg (Age 14 to < 18 Years)	Alogliptin 25 mg (Age 14 to < 18 Years)	Alogliptin 25 mg (Age 18 to 65 Years)
STARTED	5	4	8	7	22
COMPLETED	5	4	7	7	22
NOT COMPLETED	0	0	1	0	0
Voluntary Withdrawal	0	0	1	0	0

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.
Safety set: All enrolled participants who received at least 1 dose of study drug.

Reporting Groups

	Description
Alogliptin 12.5 mg (Age 10 to < 14 Years)	Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 10 to < 14 Years)	Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 12.5 mg (Age 14 to < 18 Years)	Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 14 to < 18 Years)	Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 18 to 65 Years)	Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Total	Total of all reporting groups

Baseline Measures

	Alogliptin 12.5 mg (Age 10 to < 14 Years)	Alogliptin 25 mg (Age 10 to < 14 Years)	Alogliptin 12.5 mg (Age 14 to < 18 Years)	Alogliptin 25 mg (Age 14 to < 18 Years)	Alogliptin 25 mg (Age 18 to 65 Years)	Total
Number of Participants [units: participants]	5	4	8	7	22	46
Age [units: years] Mean (Standard Deviation)	12.4 (0.89)	12.0 (0.82)	15.4 (0.92)	15.1 (0.69)	51.3 (8.24)	31.96 (19.67)
Gender [units: participants]
Female	4	3	6	5	16	34
Male	1	1	2	2	6	12
Race/Ethnicity, Customized [units: participants]
Hispanic or Latino	0	1	1	1	4	7
Non-Hispanic or Latino	5	3	7	6	18	39
Race/Ethnicity, Customized [units: participants]
Asian Black or African American	5	3	4	5	15	32
White	0	1	4	2	7	14
Height [units: cm] Mean (Standard Deviation)	162.4 (8.56)	165.8 (8.88)	168.6 (5.71)	168.9 (9.03)	167.5 (9.81)	167.2 (8.73)
Weight [units: kg] Mean (Standard Deviation)	86.62 (13.979)	98.90 (11.957)	116.28 (33.163)	103.71 (17.103)	92.25 (16.454)	97.14 (21.409)
Body Mass Index (BMI) [units: kg/m^2] Mean (Standard Deviation)	33.22 (4.621)	36.16 (3.422)	40.92 (9.190)	36.46 (6.764)	32.84 (4.490)	35.01 (6.439)
Smoking Status [units: participants]
Never Smoked	5	4	8	7	14	38
Current Smoker	0	0	0	0	0	0
Ex-smoker	0	0	0	0	8	8

Outcome Measures

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1. Primary:

Cmax: Maximum Observed Plasma Concentration for Alogliptin [ Time Frame: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose ]

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2. Primary:

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin [ Time Frame: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose ]

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3. Primary:

AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin [ Time Frame: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose ]

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4. Secondary:

Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

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5. Secondary:

Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

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6. Secondary:

Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

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7. Secondary:

Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

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8. Secondary:

Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

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9. Secondary:

Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

Show Outcome Measure 9

10. Secondary:

Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

Show Outcome Measure 10

11. Secondary:

Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

Show Outcome Measure 11

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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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: Research Organization shall not publish any articles or papers, nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data, or insights therefrom or any data, information, or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.

Results Point of Contact:

Name/Title: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT00957268 History of Changes
Other Study ID Numbers:	SYR-322_104 2009-011221-13 ( Registry Identifier: EudraCT ) U1111-1111-7810 ( Registry Identifier: WHO )
Study First Received:	August 6, 2009
Results First Received:	November 21, 2014
Last Updated:	January 26, 2015
Health Authority:	United States: Food and Drug Administration

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