A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Thyroid hormone; Drug: Sitagliptin/metformin XR; Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01557504

MK-0431A-296 (Other Identifier)

2020-003731-22 (EudraCT Number)

0431A-296

Details and patient eligibility

About

The purpose of this study is to assess:

1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years
2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets (excluding marking)
3. the pharmacokinetics of sitagliptin and metformin following the administration of two sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged 10 to 17 years.

Enrollment: 25 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participant of reproductive potential must not be pregnant and agrees to use (and/or have their partner use) two acceptable methods of birth control
• T2DM diagnosed by American Diabetes Association criteria
• No clinically significant abnormality on electrocardiogram
• No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes
• Nonsmoker

Exclusion criteria

• Mental or legal incapacitation
• Estimated creatinine clearance of 80 mL/min or lower
• History of stroke, chronic seizures, or major neurological disorder
• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of neoplastic disease
• Unable to refrain from or anticipates the use of any medication (with the exception of metformin and thyroid hormone) from approximately 2 weeks before the first dose of study drug through the poststudy visit
• Consumes alcohol or consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages
• Had surgery, donated or lost 1 unit of blood, or participated in another investigational study within the past 4 weeks
• History of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• Currently a regular user (including illicit drugs) or has a history of drug (including alcohol) abuse
• Lactose intolerant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

Sitagliptin/metformin XR followed by placebo

Experimental group

Description:

Day 1 (Period 1): participants will receive a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants will receive a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants will receive a single dose of two matching placebo tablets with the evening meal.

Treatment:

Drug: Thyroid hormone

Drug: Sitagliptin/metformin XR

Drug: Placebo

Drug: Metformin

Placebo only

Placebo Comparator group

Description:

Days 1-4 (Period 1): participants will receive a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants will receive a single dose of two matching placebo tablets with the evening meal.

Treatment:

Drug: Thyroid hormone

Drug: Placebo

Drug: Metformin