MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformain (Alone or in Combination with Insulin)

• Register: EUCTR
• Last refreshed on: 29 April 2020
• Main ID: EUCTR2012-004035-23-BG
• Date of registration: 22/01/2015
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as
• Public title: MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformain (Alone or in Combination with Insulin)
• Scientific title: A Phase III Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-Dose Combination Tablet of Sitagliptin and Extended-Release Metformin) in Pediatric Patients with Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination with Insulin) - MK-0431A XR in Pediatric Patients with T2DM and Inadequate Glycemic Control on Metformain
• Date of first enrolment: 01/04/2015
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004035-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Greece, Hungary, India, Israel, Italy, Russian Federation, South Africa

Contacts

• Name: Ravi Shankar
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

• Name: Ravi Shankar
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject has type 2 diabetes mellitus
2. Subject has an A1C =6.5% and =10.0% at Visit 1 on a stable dose of metformin (=1500 mg/day, for =12 weeks) without insulin.
Subject has an A1C =7.0% and =10.0% at Visit 1 on a stable dose of metformin (=1500 mg/day, for =12 weeks) and insulin (of any type, variance in dose to be =15% of total daily dose, for =12 weeks).
3. Subject is between 10 and 17 years of age (inclusive) on day of signing informed consent with randomization to occur prior to the subject’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: (a) Patient is a non-sterilized female who is currently not sexually active and agrees to follow statement "c" if heterosexual activity is initiated or (b) Patient agrees to abstain from heterosexual activity or (c) Patient agrees to use an adequate method of contraception.
If abstinence is not a locally acceptable method of contraception, then one other adequate birth control method must be used.
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
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:
Subject has known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies, or known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
2. Subject has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, saxagliptin, or linagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide)
3. Subject has symptomatic hyperglycemia and/or moderate to large ketonuria and/or positive test for ketonemia, requiring immediate initiation of another antihyperglycemic agent.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus
MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: MK0431A XR
Product Code: MK0431A XR
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: sitagliptin phosphate
CAS Number: 654671-78-0
Other descriptive name: SITAGLIPTIN PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Metformin
CAS Number: 657-24-9
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: MK0431A XR
Product Code: MK0431A XR
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: sitagliptin phosphate
CAS Number: 654671-78-0
Other descriptive name: SITAGLIPTIN PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Metformin
CAS Number: 657-24-9
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Glucophage XR
Product Name: Metformin Hydrochloride
Product Code: Metformin Hydrochloride
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Metformin
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Glucophage XR
Product Name: Metformin Hydrochloride
Product Code: Metformin Hydrochloride
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Metformin
Other descriptive name: METFORMIN HYDROCHLORIDE
C

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 20 Weeks

Main Objective: For MK-0431A XR P289:
(1) Over 54 weeks, to assess the safety and tolerability of the addition of sitagliptin (administered as MK-0431A XR) in pediatric patients (10-17 yrs) with T2DM with inadequate glycemic control on metformin therapy (Alone or in Combination with Insulin)
Subjects from MK-0431A XR P289 Phase A and MK-0431A P170 base study:
(2) after 20 weeks, to assess the effect of the addition of sitagliptin
(administered as MK-0431A XR, relative to the addition of placebo on A1C in pediatric patients (10-17 yrs) with T2DM with inadequate glycemic control on metformin therapy (Alone or in Combination with Insulin)
Subjects from MK-0431A XR P289 Phases A+B and MK-0431A P170 base and extension studies:
(3) Over 54 weeks, to assess the safety and tolerability of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) in pediatric patients (10-17 yrs) with T2DM with inadequate glycemic control on metformin therapy (Alone or in Combination with Insulin)

Primary end point(s): Change from baseline in A1C at Week 20

Secondary Objective: In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control on metformin therapy (Alone or in Combination with Insulin:
For the pooled study population (subjects from MK-0431A XR P289 Phase A and MK-0431A P170 base study)-
(1) Objective: After 20 weeks, to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to placebo on fasting plasma glucose (FPG)
(2) Objective: After 20 weeks, to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to placebo on the proportion of subjects initiation glycemic rescue therapy
(3) Objective: After 20 weeks, to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to placebo on the proportion of subjects with A1C at goal (<7.0%)

Secondary Outcome(s)

Secondary end point(s): Change from baseline in A1C at Week 54
Proportion of subject meeting A1C goals (<7.0%, <6.5%) at Week 20 and Week 54
Change from baseline in FPG at Week 20 and Week 54
Proportion of subjects initiating glycemic rescue therapy by Week 20
Proportion of subjects initiating insulin glargine at/after Week 20

Timepoint(s) of evaluation of this end point: Week 20, Week 54

Secondary ID(s)

0431A-0289

2012-004035-23-CZ

Source(s) of Monetary Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

Ethics review

Status: Approved
Approval date: 25/03/2015
Contact:

Results

• Results available: Yes
• Date Posted: 25/03/2020
• Date Completed: 17/09/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004035-23/results