MK-0431A XR in Pediatric Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformain

• Register: EUCTR
• Last refreshed on: 17 August 2015
• Main ID: EUCTR2012-004035-23-Outside-EU/EEA
• Date of registration: 04/08/2015
• 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
• 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 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
• Target sample size: 90
• Recruitment status: NA
• 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

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Georgia, Guatemala, Honduras, India, Israel, Mauritius, Mexico, Moldova, Republic of, New Zealand, Panama, Philippines, Russian Federation, Saudi Arabia, Serbia, South Africa, Sri Lanka, Taiwan, Ukraine

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 is on a stable dose of metformin (=1500 mg/day, for =12 weeks) without insulin and with A1C =6.5% and =10.0%, OR (b) Subject is on stable doses 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 prior to Screening Visit/ Visit 1) with an A1C=7.0% and =10%.
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. Subject has not received treatment with insulin for at least 6 months prior to the Screening Visit/Visit 1
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: 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

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

Type 2 Diabetes Mellitus
MedDRA version: 18.0 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-
INN or Proposed INN: METFORMIN HYDROCHLORIDE
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
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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-
INN or Proposed INN: METFORMIN HYDROCHLORIDE
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
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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
Other descriptive name: N, N-dimethylimidodicarbonimidic diamide hydrochloride
Concentration unit: mg milligram(s)
Concentration

Primary Outcome(s)

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

Main Objective: In pediatric subjects with inadequate control on metformin therapy (alone or in combination with insulin):
(1) To assess the safety and tolerability of the addition of sitagliptin (administered as MK-0431A XR) over 54 weeks in the MK-0431A XR Protocol 289 population.
(2) To assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to the addition of placebo on A1C over 20 weeks in a pooled study population (subjects from MK-0431A XR P289 Phase A and MK-0431A P170 base study).
(3) To assess the safety and tolerability of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) over 54 weeks in a pooled study population (subjects from MK-0431A XR P289 Phases A+B and MK-0431A P170 base and extension studies).

Secondary Objective: In pediatric subjects with inadequate control on metformin therapy (alone or in combination with insulin):
(1) 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), the proportion of patients initiating glycemic rescue therapy, and the proportion of patients with A1C at goal (<7.0%) after 20 weeks in a pooled study population (subjects from MK-0431A XR P289 Phase A and MK-0431A P170 base study).
(2) To assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) on the change from baseline in A1C, the change from baseline in FPG, and the proportion of patients with A1C at goal (<7.0%) after 54 weeks in a pooled study population (subjects from MK-0431A XR P289 Phases A+B and MK-0431A P170 base and extension studies).

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 20 weeks (FPG, proportion of subjects meeting A1C goals, proportion of subjects initiating insulin glargine at/after Week 20, proportion of subjects initiating glycemic rescue by Week 20) and 54 weeks (A1C, FPG, proportion of subjects meeting A1C goals).

Secondary end point(s): Change from baseline in A1C and fasting plasma glucose, proportion of subjects initiating glycemic rescue therapy, proportion of subjects meeting A1C goals, proportion of subjects initiating insulin glargine.

Secondary ID(s)

2012-004035-23-CZ

0431A-289

Source(s) of Monetary Support

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