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

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ClinicalTrials.gov Identifier: NCT00730275
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : January 30, 2012
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin phosphate Drug: Comparator: matching placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents
Actual Study Start Date : July 18, 2008
Primary Completion Date : December 30, 2010
Study Completion Date : February 14, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sitagliptin 50 mg
Participants were randomized to sitagliptin 50 mg
Drug: Sitagliptin phosphate
Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.
Other Names:
  • MK-0431
  • Januvia
Experimental: Sitagliptin 100 mg
Participants were randomized to sitagliptin 100 mg
Drug: Sitagliptin phosphate
Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.
Other Names:
  • MK-0431
  • Januvia
Experimental: Sitagliptin 200 mg
Participants were randomized to a single dose of sitagliptin 200 mg
Drug: Sitagliptin phosphate
Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.
Other Names:
  • MK-0431
  • Januvia
Placebo Comparator: Placebo to sitagliptin
Participants were randomized to matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg
Drug: Comparator: matching placebo
Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Pre-study through 10 to 14 days following administration of study drug ]
  2. 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 ]
    Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.


Secondary Outcome Measures :
  1. Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin [ Time Frame: Pre-dose through 72 hours post-dose ]
    Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.

  2. Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin [ Time Frame: Pre-dose through 72 hours post-dose ]
    Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.

  3. Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin [ Time Frame: Pre-dose through 72 hours post-dose ]
    Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.

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

    Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose.

    WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females who are 10 - 17 years of age
  • History of type 2 diabetes
  • Nonsmoker
  • No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

Exclusion Criteria:

  • History of diabetic ketoacidosis
  • History of stroke, chronic seizures or major neurological disorder
  • Consumes alcohol
  • Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other beverages containing caffeine per day
  • Unable to swallow tablets
  • Has had surgery, donated or lost 1 unit of blood, or participated in another investigational study within a minimum of 4 weeks prior to starting the study
  • History of multiple and/or severe allergies or has had an allergic reaction to or significant intolerability to prescription or non-prescription drugs or food
  • Currently a regular user of any illicit drugs or has a history of drug or alcohol abuse
  • History of clinically significant endocrine, gastrointestinal,

cardiovascular, hematological, hepatic, immunological, renal, respiratory, or

genitourinary abnormalities or diseases

  • Has an estimated creatinine clearance of less than or equal to 80 mL/min
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730275


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00730275     History of Changes
Other Study ID Numbers: 0431-081
2008_540
First Posted: August 8, 2008    Key Record Dates
Results First Posted: January 30, 2012
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action