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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730275
First Posted: August 8, 2008
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.

Condition Intervention Phase
Type 2 Diabetes Drug: Sitagliptin phosphate Drug: Comparator: matching placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

  • 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.

  • 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.

  • 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.



Enrollment: 35
Actual Study Start Date: July 18, 2008
Study Completion Date: February 14, 2011
Primary Completion Date: December 30, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: December 21, 2011
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