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

NCT00730275 | Completed Phase 1 Results

• 2 other identifiers: 0431-0812008_540
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced at Least One Adverse Event

  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

  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.

  Pre-dose through 72 hours post-dose

Secondary Outcomes (4)

• Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin

  Pre-dose through 72 hours post-dose

• Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin

  Pre-dose through 72 hours post-dose

• Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin

  Pre-dose through 72 hours post-dose

• Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo

  Pre-dose through 24 hours post-dose

Study Arms (4)

Sitagliptin 50 mg

EXPERIMENTAL

Participants were randomized to sitagliptin 50 mg

Drug: Sitagliptin phosphate

Sitagliptin 100 mg

EXPERIMENTAL

Participants were randomized to sitagliptin 100 mg

Drug: Sitagliptin phosphate

Sitagliptin 200 mg

EXPERIMENTAL

Participants were randomized to a single dose of sitagliptin 200 mg

Drug: Sitagliptin phosphate

Placebo to sitagliptin

PLACEBO COMPARATOR

Participants were randomized to matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg

Drug: Comparator: matching placebo

Interventions

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.

Also known as: MK-0431, Januvia

Sitagliptin 100 mg; Sitagliptin 200 mg; Sitagliptin 50 mg

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.

Placebo to sitagliptin

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Fraser IP, Neufeld ND, Fox LA, Kipnes MS, Miller TL, Zeitler PS, Rodriguez H, Gilmartin JH, Lee SJ, Patterson JK, Li XS, Maganti L, Luo WL, Tatosian DA, Stoch SA. A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes. Pediatr Diabetes. 2019 Feb;20(1):48-56. doi: 10.1111/pedi.12790. Epub 2018 Nov 13.

  PMID: 30346099 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharpe & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: July 18, 2008
• Primary Completion: December 30, 2010
• Study Completion: February 14, 2011
• Last Updated: May 12, 2017
• Results First Posted: January 30, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share