Type 2 Diabetes Mellitus MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: JANUVIA
Product Name: Sitagliptin
Product Code: MK-0431
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SITAGLI
Sponsors
Merck Sharp & Dohme Corp. A subsidiary of Merck & Co. Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has type 2 diabetes mellitus (T2DM). 2. Patient has not treatment with an oral AHA for =12 weeks prior to the Screening Visit / Visit 1, or with insulin for at least 12 weeks prior to the Screening Visit / Visit 1. 3. Patient has an A1C of =6.5% and =10.0%. Note: Patients on insulin have an A1C =7.0% and =10.0% 4. Patient is 10 and 17 years of age on day of signing informed consent with randomization to occur prior to the patient's 18th birthday. 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 nonsterilized 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. 6. Sub-Study Inclusion Criteria: Patient was randomized into P083 and has taken at least one dose of study medication, including new and ongoing patients (on or off study medication), and patients who previously completed 54 weeks of the main study. Are the trial subjects under 18? yes Number of subjects for this age range: 170 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
Exclusion criteria: 1. Patient has (1) a history of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD or ICA- 512, or (2) known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes 2. Patient has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of antihyperglycemic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control: (1) after 20 weeks, to assess the effect of treatment with sitagliptin compared with placebo on A1C (2) to assess the safety and tolerability of sitagliptin ; Secondary Objective: In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control, after 20 weeks and 54 weeks (1) to assess effect of treatment with sitagliptin compared to placebo on fasting plasma glucose (FPG) (2) to assess the effect of treatment with sitagliptin compared with placebo on the proportion of patients requiring glycemic rescue therapy Sub-Study Objective is to enhance the dental data collected from the visual oral examination (VOE) to support secondary objectives to summarize data on the change from baseline in measures of dentition at Week 20 and Week 54 ;Primary end point(s): Change from baseline in hemoglobin A1c (A1C) ;Timepoint(s) of evaluation of this end point: 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline fasting plasma glucose (FPG);Timepoint(s) of evaluation of this end point: 20 weeks and 54 weeks | — |
Countries
Argentina, Austria, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, Israel, Italy, Latvia, Lithuania, Malaysia, Mauritius, Mexico, Moldova, Republic of, New Zealand, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Thailand, United Arab Emirates, United Kingdom, United States
Contacts
Public ContactClinical Trial Department
SIA „MERCK SHARP & DOHME LATVIJA“
Outcome results
None listed