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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)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Sitagliptin/metformin XR (Drug); Placebo (Drug); Metformin (Drug); Thyroid hormone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

Official title: A Study to Assess the Pharmacokinetics and the Ability for Pediatric Patients With Type 2 Diabetes to Swallow MK-0431A XR Tablets

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2

Number of Participants Who Successfully Swallowed Study Med on Day 4

Number of Participants Who Successfully Swallowed Study Med on Day 6

Number of Participants Who Successfully Swallowed Study Med on Day 9

Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR

AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR

AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR

Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR

Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR

Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR

Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR

Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR

Number of Participants Who Experienced an Adverse Event (AE)

Number of Participants Who Experienced an Abnormal Vital Sign Value

Number of Participants Who Discontinued Study Drug Due to an AE

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: July 2012
Last updated: May 6, 2015

Page last updated: August 23, 2015

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