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Completed

NCT Number: NCT00730275

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin phosphate

Drug

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

Comparator: matching placebo

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 8, 2008
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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