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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00730275
First received: August 6, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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:


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 ] [ 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730275

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00730275     History of Changes
Other Study ID Numbers: 0431-081, 2008_540
Study First Received: August 6, 2008
Results First Received: December 21, 2011
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014