A Study of Sitagliptin/Metformin in Pediatric Patients with Type 2 Diabetes Mellitus not Controlled on Metformi

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-002529-23-DE
• Lead Sponsor: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-20
• Study Completion: 2019-09-17
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

1. Patient has type 2 Diabetes
2. Patient on metformin monotherapy (=1500 mg/day, for =12 weeks) with A1C =6.5% and =10.0%
3. Patient is =10 and 17 years of age on day of signing informed consent with randomization to occur prior to the patient's 18th birthday.
4. Patient is either a male, or patient is a female who is unlikely to conceive as indicated by at least one yes response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study medication
5. Parent/guardian understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily
agrees to the patient's participation by giving informed written consent, and the patient has an age-appropriate understanding of the same to
give informed written assent.
6. Patient and a family member or adult closely involved in the patient's daily activities (in the opinion of the Investigator) will participate in the
patient's treatment and study protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
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

Exclusion Criteria

1. Patient has known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was
diagnosed with diabetes).
2. Patient has known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other
than diabetes.
3. Patient has symptomatic hyperglycemia and/or moderate to large ketonuria and/or positive test for ketonemia, requiring immediate initiation of another antihyperglycemic agent.
4. Patient has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as
exenatide or liraglutide).
5. Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks of signing the informed consent (including patients who have participated in single-dose studies with these agents) and does not agree to refrain from participating in any other study while participating in this study.
6. Patient is on or likely to require treatment with =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
7. Patient has a history of congenital heart disease or cardiovascular disease other than hypertension.
8. Patient has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease.
9. Patient has active nephropathy (ie, nephrotic syndrome or glomerulonephritis).
10. Patient has chronic myopathy, mitochondrial disorder or a progressive neurological or neuromuscular disorder (eg, polymyositis or multiple sclerosis).
11. Patient has a known history of recreational or illicit drug use, or of alcohol abuse or dependence (within the past year).
12. Patient is pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose
of study medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control on metformin monotherapy: (1) after 20 weeks, to assess the effect of the addition of sitagliptin compared with the addition of placebo on A1C (2) to assess the safety and tolerability of the addition of sitagliptin.;Secondary Objective: In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control on metformin monotherapy, after 20 weeks: (1) to assess the effect of the addition of sitagliptin compared with the addition of placebo on fasting plasma glucose (FPG) (2) to assess the effect of the addition of sitagliptin compared with the addition of placebo on the proportion of patients requiring glycemic rescue therapy.;Primary end point(s): hemoglobin A1c (A1C) ;Timepoint(s) of evaluation of this end point: 20 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): fasting plasma glucose (FPG);Timepoint(s) of evaluation of this end point: 20 weeks