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

• Register: EUCTR
• Last refreshed on: 20 April 2020
• Main ID: EUCTR2014-003583-20-DE
• Date of registration: 12/09/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc
• Public title: A Study of Sitagliptin/Metformin in Pediatric Patients with Type 2 Diabetes Mellitus not Controlled on Metformin
• Scientific title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo -Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients with Type 2 Diabetes Mellitus) AND A 34-week Follow-Up to: A Phase III, Multicenter, Double-Blind, Randomized, Placebo -Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients with Type 2 Diabetes Mellitus) - MK-0431A in Pediatric Patients with Type 2 Diabetes Mellitus
• Date of first enrolment: 30/12/2014
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003583-20
• 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

Argentina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Germany, Guatemala, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Peru, Romania, Russian Federation, Saudi Arabia, Singapore, Thailand, Turkey, United Arab Emirates, United Kingdom, United States

Contacts

• Name: Clinical Monitor
• Affiliation: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc

• Name: Clinical Monitor
• Affiliation: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient has completed the P170 base study on double-blind study medication.
2. 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
Note: If abstinence is not a locally acceptable method of contraception, then one
other adequate birth control method must be used.
or
c) Patient agrees to use an adequate method of contraception.
Note: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation
methods) and withdrawal are not acceptable methods of contraception.
Adequate methods of birth control are: hormonal contraceptive, intrauterine
device (IUD), diaphragm with spermicide, contraceptive sponge, or use of
condom by the partner. Patients initiating hormonal contraception during the
study should use one additional method during the first 2 months.
Are the trial subjects under 18? yes
Number of subjects for this age range: 240
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 meets a discontinuation criterion of P170 at the last visit of the base study
(Week 20).
2. Patient has taken the last dose of study medication for the P170 base study more than
14 days prior to Extension Visit 1.
3. Patient has initiated another open-label antihyperglycemic agent as add-on to
metformin.
4. Patient does not agree to refrain from participating in any other double-blind
interventional study while participating in this extension study.
5. Patient is unlikely to adhere to the study procedures and appointment schedule, has
poor mental function or parent/guardian is, in the opinion of the investigator, mentally
or legally incapacitated preventing informed consent from being obtained.
6. Patient has a history or current evidence of any condition, therapy, lab abnormality or
other circumstance which, in the opinion of the investigator, might pose a risk to the
patient, or make participation not in the patient’s best interest.


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: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Intervention(s)

Product Name: Sitagliptin Phosphate (+) Metformin Hydrochloride Tablet
Product Code: MK-0431A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: SITAGLIPTIN
CAS Number: 654671-78-0
Current Sponsor code: MK-0431
Other descriptive name: SITAGLIPTIN PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Metformin Hydrochloride Tablets 500 mg, USP
Product Name: Metformin Hydrochloride
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Metformin Hydrochloride Tablets 850 mg, USP
Product Name: Metformin hydrochloride
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Metformin Hydrochloride Tablets 1000 mg, USP
Product Name: Metformin hydrochloride
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral u

Primary Outcome(s)

Primary end point(s): hemoglobin A1c (A1C)

Timepoint(s) of evaluation of this end point: 54 weeks

Main Objective: For MK-0431A P170 [MK-0431A P170 (base + extension study)]:
(1) Objective: Over 54 weeks, to assess the safety and tolerability of the addition of
sitagliptin (administered as MK-0431A) in pediatric patients (ages 10-17 years) with
T2DM with inadequate glycemic control on metformin monotherapy.
For the pooled study population [MK-0431A P170 (base + extension study) and MK-
0431A XR P289 (Phase A + B)]:
(1) Objective: 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 (ages
10-17 years) with T2DM with inadequate glycemic control on metformin
monotherapy.

Secondary Objective: For the pooled study population [MK-0431A P170 (base + extension study) and
MK-0431A XR P289 (Phase A + B)]:
(1) Objective: After 54 weeks, to assess the effect of the addition of sitagliptin
(administered as MK-0431A or MK-0431A XR) on the changes from baseline in
A1C and in pediatric patients (ages 10-17 years) with T2DM with inadequate
glycemic control on metformin monotherapy.
(2) Objective: After 54 weeks, to assess the effect of the addition of sitagliptin
(administered as MK-0431A or MK-0431A XR) on the changes from baseline in FPG
in pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control
on metformin monotherapy.
(3) Objective: After 54 weeks, to assess the effect of the addition of sitagliptin
(administered as MK-0431A or MK-0431A XR) on the proportion of patients with
A1C at goal (<7.0%) in pediatric patients (ages 10-17 years) with T2DM with
inadequate glycemic control on metformin monotherapy.

Secondary Outcome(s)

Secondary end point(s): fasting plasma glucose (FPG)

Timepoint(s) of evaluation of this end point: 54 weeks

Secondary ID(s)

0431A-170-03

Source(s) of Monetary Support

Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc

Ethics review

Status: Approved
Approval date: 30/12/2014
Contact:

Results

• Results available: Yes
• Date Posted: 25/03/2020
• Date Completed: 17/09/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-003583-20/results