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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:
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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Merck:

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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
Study Start Date: July 2008
Study Completion Date: February 2011
Primary Completion Date: December 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

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730275

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013