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

NCT ID: NCT00730275

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-18
• Study Completion Date: 2011-02-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sitagliptin 50 mg

Participants were randomized to sitagliptin 50 mg

Group Type: EXPERIMENTAL

Sitagliptin phosphate

Intervention Type: 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.

Sitagliptin 100 mg

Participants were randomized to sitagliptin 100 mg

Group Type: EXPERIMENTAL

Sitagliptin phosphate

Intervention Type: 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.

Sitagliptin 200 mg

Participants were randomized to a single dose of sitagliptin 200 mg

Group Type: EXPERIMENTAL

Sitagliptin phosphate

Intervention Type: 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.

Placebo to sitagliptin

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

Group Type: PLACEBO_COMPARATOR

Comparator: matching placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MK-0431; Januvia

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 30346099 (View on PubMed)

Other Identifiers

2008_540

Identifier Type: -

Identifier Source: secondary_id

0431-081

Identifier Type: -

Identifier Source: org_study_id