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

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Hide Baseline Characteristics

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

Show All Outcome Measures

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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Show More Information

To Top