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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Sitagliptin phosphate; Drug: Comparator: matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730275

2008_540

0431-081

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 4 patient groups, including a placebo group

Sitagliptin 50 mg

Experimental group

Description:

Participants were randomized to sitagliptin 50 mg

Treatment:

Drug: Sitagliptin phosphate

Sitagliptin 100 mg

Experimental group

Description:

Participants were randomized to sitagliptin 100 mg

Treatment:

Drug: Sitagliptin phosphate

Sitagliptin 200 mg

Experimental group

Description:

Participants were randomized to a single dose of sitagliptin 200 mg

Treatment:

Drug: Sitagliptin phosphate

Placebo to sitagliptin

Placebo Comparator group

Description:

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

Treatment:

Drug: Comparator: matching placebo