A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170 AM1)

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT01472367
• Date of registration: 11/11/2011
• Primary sponsor: Merck
• Public title: A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170 AM1)
• 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
• Date of first enrolment: December 2011
• Target sample size: 240
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01472367
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

Canada, Chile, Colombia, Dominican Republic, Ecuador, Germany, Guatemala, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Romania, Russian Federation, Thailand, United Arab Emirates, United Kingdom, United States

Contacts

• Name: Toll Free Number

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has Type 2 Diabetes Mellitus (T2DM)

- Has not received treatment with insulin for at least 6 months prior to the Screening
Visit/Visit 1.

- A1C greater than or equal to 7.0% and less than or equal to 10.0% on metformin,
greater than or equal to 1500 mg/day, for greater than or equal to 12 weeks. NOTE:
Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but
less than 1500 mg/day may be eligible if there is documentation that higher doses are
not tolerated.

- Between 10 and 17 years of age on day of signing informed consent with randomization
to occur prior to 18th birthday.

- Participant and a family member or adult closely involved in the daily activities
will participate in the participant's treatment and study protocol (i.e., available
for telephone calls, study visits and administration of study medication as needed).

Exclusion Criteria:

- Known type 1 diabetes mellitus or documented evidence of positive diabetes
auto-antibodies (if performed when patient was diagnosed with diabetes).

- Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known
to affect glucose tolerance other than diabetes.

- Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate
initiation of another antihyperglycemic agent.

- Participant has previously taken a DPP-4 inhibitor (such as sitagliptin,
vildagliptin,alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide
or liraglutide).

- Exhibits abnormal growth patterns or is being treated with growth hormone.

- History of idiopathic acute pancreatitis or chronic pancreatitis.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Metformin

Drug: Placebo to Metformin

Drug: Placebo to Sitagliptin / Metformin

Drug: Sitagliptin / Metformin

Primary Outcome(s)

Change from baseline in Hemoglobin A1c (A1C) at Week 20 [Time Frame: Baseline and Week 20]

Number of participants with adverse events [Time Frame: 20 weeks]

Secondary ID(s)

0431A-170

Source(s) of Monetary Support

Please refer to primary and secondary sponsors