Type 2 Diabetes Mellitus MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
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
Sponsors
Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Primary end point(s): hemoglobin A1c (A1C) ;Timepoint(s) of evaluation of this end point: 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): fasting plasma glucose (FPG);Timepoint(s) of evaluation of this end point: 54 weeks | — |
Countries
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
Public ContactClinical Monitor
Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc
Outcome results
None listed