A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170)
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 7/28/2018 |
| Start Date: | December 7, 2011 |
| End Date: | January 23, 2020 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
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 With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin)
The purpose of the study is to assess the safety of the addition of sitagliptin, and its
effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients
requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with
type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy (alone
or in combination with insulin). The primary hypothesis is that the addition of sitagliptin
reduces A1C more than the addition of placebo after 20 weeks of treatment. Participants who
complete the 20-week base period of the study may choose to participate in the extension
period of the study and continue on or off treatment assigned during the base period for an
additional 34 weeks.
effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients
requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with
type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy (alone
or in combination with insulin). The primary hypothesis is that the addition of sitagliptin
reduces A1C more than the addition of placebo after 20 weeks of treatment. Participants who
complete the 20-week base period of the study may choose to participate in the extension
period of the study and continue on or off treatment assigned during the base period for an
additional 34 weeks.
Inclusion Criteria:
- Has Type 2 Diabetes Mellitus (T2DM)
- Is on metformin monotherapy (≥1500 mg/day) for ≥12 weeks with A1C ≥6.5% and ≤10.0% OR
is on stable doses of metformin (≥1500 mg/day) and insulin for ≥12 weeks with an A1C
≥7.0% and ≤10%. 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 participant 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 dipeptidyl peptidase-IV (DPP-4) inhibitor (such as
sitagliptin, vildagliptin, alogliptin, or saxagliptin) or glucagon-like peptide-1
(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.
We found this trial at
5
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials