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

• Register: EUCTR
• Last refreshed on: 16 December 2019
• Main ID: EUCTR2012-004035-23-DK
• Date of registration: 09/08/2013
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Therapy (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 Metformin Therapy
• Date of first enrolment: 13/08/2013
• 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, 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. Patient has type 2 diabetes mellitus
2. Patient has an A1C =6.5% and =10.0% on a stable dose of metformin IR or XR (=1500 mg/day) for =12 weeks before Visit 1
3. Patient 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 on stable doses of metformin and insulin for =12 weeks with an A1C=7.0% and =10.0%
5. 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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, or known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
2. Patient 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. Patient has symptomatic hyperglycemia and/or moderate ketonuria requiring immediate initiation of another antihyperglycemic agent.



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

Health Condition(s) or Problem(s) studied

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

Type 2 Diabetes Mellitus
MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Product Name: MK0431A XR
Product Code: MK0431A XR
Pharmaceutical Form: 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-
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: 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-
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 Extended Release
Product Code: Metformin Hydrochloride Extended Release
Pharmaceutical Form: Tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 657-24-9
Other descriptive name: N, N-dimethylimidodicarbonimidic diamide hydrochloride
Concentration unit: mg milligram(s)
Concentrati

Primary Outcome(s)

Secondary Objective: In pediatric subjects with T2DM with inadequate glycemic control on metformin therapy (alone or in combination with insulin):
1. For the pooled study population (MK-0431A XR P289 Phase A and MK-0431 A P170 base study): After 20 weeks, assess the effect of the addition of sitagliptin (MK-0431A XR) compared with the addition of placebo on FPG, proportion of subjects initiating rescue, proportion of subjects with A1C at goal.
2. For the pooled study population (MK-0431A XR P289 Phase A+B and MK-0431 A P170 base and extension studies): After 54 weeks, assess the effect of the addition of sitagliptin (MK-0431-A or MK-0431A XR) on the change from baseline in A1C and in FPG and on the proportion of subjects with A1C at goal.

Main Objective: In pediatric subjects with T2DM with inadequate glycemic control on metformin therapy (alone or in combination with insulin):
1. For MK-0431A XR P289: Over 54 weeks, assess the safety and tolerability of the addition of sitagliptin (MK-0431A XR)
2. For the pooled study population (MK-0431A XR P289 Phase A and MK-0431 A P170 base study): After 20 weeks, assess the effect of the addition of sitagliptin (MK-0431A or MK-0431A XR) relative to the addition of placebo on A1C
3. For the pooled study population (MK-0431A XR P289 Phase A+B and MK-0431 A P170 base and extension studies): Over 54 weeks, assess the safety and tolerability of the addition of sitagliptin (MK-0431A or MK-0431A XR)

Primary end point(s): A1C

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

Secondary Outcome(s)

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

Secondary end point(s): Fasting plasma glucose, proportion of subjects initiating glycemic rescue, proportion of subjects with A1C at goal

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:
Contact: