A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00730275

First received: August 6, 2008

Last updated: December 21, 2011

Last verified: December 2011

History of Changes

Results First Received: December 21, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: Sitagliptin phosphate Drug: Comparator: matching 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sitagliptin 50 mg	Participants who received a single oral dose of sitagliptin 50 mg.
Sitagliptin 100 mg	Participants who received a single oral dose of sitagliptin 100 mg.
Sitagliptin 200 mg	Participants who received a single oral dose of sitagliptin 200 mg.
Placebo	Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.

Participant Flow: Overall Study

	Sitagliptin 50 mg	Sitagliptin 100 mg	Sitagliptin 200 mg	Placebo
STARTED	9	9	8	9
COMPLETED	9	9	8	8
NOT COMPLETED	0	0	0	1
Withdrawal by Subject	0	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin 50 mg	Participants who received a single oral dose of sitagliptin 50 mg.
Sitagliptin 100 mg	Participants who received a single oral dose of sitagliptin 100 mg.
Sitagliptin 200 mg	Participants who received a single oral dose of sitagliptin 200 mg.
Placebo	Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
Total	Total of all reporting groups

Baseline Measures

	Sitagliptin 50 mg	Sitagliptin 100 mg	Sitagliptin 200 mg	Placebo	Total
Number of Participants [units: participants]	9	9	8	9	35
Age [units: years] Mean ± Standard Deviation	13.9 ± 2.52	14.3 ± 1.41	14.8 ± 1.75	14.1 ± 2.26	14.3 ± 1.98
Gender [units: participants]
Female	6	5	5	8	24
Male	3	4	3	1	11

Outcome Measures

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1. Primary:

Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Pre-study through 10 to 14 days following administration of study drug ]

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2. Primary:

Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin [ Time Frame: Pre-dose through 72 hours post-dose ]

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3. Secondary:

Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin [ Time Frame: Pre-dose through 72 hours post-dose ]

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4. Secondary:

Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin [ Time Frame: Pre-dose through 72 hours post-dose ]

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5. Secondary:

Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin [ Time Frame: Pre-dose through 72 hours post-dose ]

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6. Secondary:

Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo [ Time Frame: Pre-dose through 24 hours post-dose ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Sitagliptin 50 mg	Participants who received a single oral dose of sitagliptin 50 mg.
Sitagliptin 100 mg	Participants who received a single oral dose of sitagliptin 100 mg.
Sitagliptin 200 mg	Participants who received a single oral dose of sitagliptin 200 mg.
Placebo	Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.

Other Adverse Events

	Sitagliptin 50 mg	Sitagliptin 100 mg	Sitagliptin 200 mg	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	3/9	1/9	1/8	2/9
Blood and lymphatic system disorders
Anaemia
# participants affected / at risk	0/9 (0.00%)	0/9 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Gastrointestinal disorders
Abdominal pain
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Abdominal pain upper
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Diarrhoea
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Vomiting
# participants affected / at risk	0/9 (0.00%)	0/9 (0.00%)	1/8 (12.50%)	0/9 (0.00%)
General disorders
Infusion site pain
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Infusion site swelling
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Pyrexia
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Metabolism and nutrition disorders
Hypoglycaemia
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Nervous system disorders
Headache
# participants affected / at risk	0/9 (0.00%)	0/9 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Reproductive system and breast disorders
Dysmenorrhoea
# participants affected / at risk	1/9 (11.11%)	0/9 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion
# participants affected / at risk	0/9 (0.00%)	0/9 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Oropharyngeal pain
# participants affected / at risk	0/9 (0.00%)	0/9 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Vascular disorders
Phlebitis
# participants affected / at risk	0/9 (0.00%)	1/9 (11.11%)	0/8 (0.00%)	0/9 (0.00%)

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 sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

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
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Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharpe & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00730275 History of Changes
Other Study ID Numbers:	MK-0431-081, 2008_540
Study First Received:	August 6, 2008
Results First Received:	December 21, 2011
Last Updated:	December 21, 2011
Health Authority:	United States: Food and Drug Administration

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