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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Sitagliptin phosphate

• Registration Number: NCT00730275
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-18
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-08
• Primary Completion: 2010-12-30
• Study Completion: 2011-02-14
• Results First Submitted: 2011-12-21
• Results First Submitted QC: 2011-12-21
• Results First Posted: 2012-01-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin 50 mg	Sitagliptin phosphate	Participants were randomized to sitagliptin 50 mg
Sitagliptin 200 mg	Sitagliptin phosphate	Participants were randomized to a single dose of sitagliptin 200 mg
Sitagliptin 100 mg	Sitagliptin phosphate	Participants were randomized to sitagliptin 100 mg

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin	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.
Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin	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.
Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo	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.
Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin	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.