A Study of the Safety and Efficacy of MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-289)



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 17
Updated:8/23/2018
Start Date:February 17, 2013
End Date:October 15, 2019
Contact:Toll Free Number
Phone:1-888-577-8839

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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 Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin)

The purpose of this study is to assess the safety and efficacy of the addition of sitagliptin
(administered as MK-0431A XR) compared with the addition of placebo to therapy with
extended-release metformin (metformin XR) for the treatment of type 2 diabetes mellitus
(T2DM) in pediatric participants with inadequate glycemic control on metformin therapy (alone
or in combination with insulin). The primary hypothesis is that the addition of sitagliptin
reduces hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of treatment.


Inclusion Criteria:

- Has T2DM

- A1C greater than or equal to 6.5% and less than or equal to 10.0% on metformin
(greater than or equal to 1500 mg/day) without insulin for greater than or equal to 12
weeks OR A1C greater than or equal to 7% and less than or equal to 10.0% on metformin
(greater than or equal to 1500 mg/day) and insulin 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 for greater than or equal to 12 weeks may be
eligible if there is documentation that higher doses are not tolerated.

- Between 10 and 17 years of age (inclusive)

- Male, or female who is unlikely to conceive (non-sterilized, and is not sexually
active or agrees to abstain from heterosexual activity or agrees to use an adequate
method of contraception) during the study and for 14 days after the last dose of study
drug

Exclusion Criteria:

- Has type 1 diabetes mellitus

- Has monogenic diabetes or secondary diabetes

- Has previously taken a dipeptidyl peptidase IV (DPP-4) inhibitor (such as sitagliptin,
vildagliptin, alogliptin, saxagliptin, or linagliptin) or glucagon-like peptide-1
(GLP-1) receptor agonist (such as exenatide or liraglutide)

- Is on or likely to require treatment for > or =2 consecutive weeks or repeated courses
of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)

- Has undergone a surgical procedure within 4 weeks of study participation or has
planned major surgery during the study

- History of congenital heart disease or cardiovascular disease other than hypertension

- History of active liver disease (other than non-alcoholic steatosis), including
chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder
disease

- Active neuropathy (such as nephrotic syndrome or glomerulonephritis)

- Chronic myopathy, mitochondrial disorder or a progressive neurological or
neuromuscular disorder

- Human immunodeficiency virus (HIV)

- Hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative
or myelodysplastic syndromes)

- Is currently being treated for hyperthyroidism or is on thyroid hormone therapy and
has not been on a stable dose for at least 6 weeks

- History of malignancy for < or =5 years prior to study participation, except for
adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer

- History of idiopathic acute pancreatitis or chronic pancreatitis

- History of recreational or illicit drug use, or of alcohol abuse or

dependence (within the past year)

- Has donated blood products or has had phlebotomy of >10% of estimated

total blood volume within 8 weeks of study participation, or intends to donate

blood products or receive blood products within the projected duration of the study

- Is pregnant or breast-feeding, or is expecting to conceive or donate eggs during the
study, including 14 days following the last dose of study drug
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2841 Cazadores de Coquimbo
Buenos Aires, B1605
Phone: 54 11 6090 7336
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