A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents
- Conditions
- Type 2 Diabetes MellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-004993-40-Outside-EU/EEA
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 35
•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
•See protocol for complete list of inclusion criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
•Refer to protocol for complete list.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method