Type 2 Diabetes Mellitus MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: JANUMET
Product Code: MK-0431A
Pharmaceutical Form: Tablet
CAS Number: 1115-70-4
Other descriptive name: METFORMIN HYDROCHLO
Sponsors
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Base study: 1. Patient has type 2 diabetes mellitus (T2DM). 2. Patient has not received treatment with insulin for at least 12 weeks prior to the Screening Visit/Visit 1. However, patients who have had no more than a total of 3 days of treatment with insulin during the 12 weeks prior to the Screening Visit/Visit 1 are eligible. Note: For patients who have received treatment with insulin for more than 3 days within the 12 weeks prior to the Screening Visit/Visit 1, therapy should not be stopped (washed-off) to make them eligible for the study. 3. Patient has an A1C =6.5% and =10.0% on metformin, =1500 mg/day, for =12 weeks. Note: -Patients on stable doses of metformin =1000 and <1500 mg/day for =12 weeks can participate if there is documentation that they cannot tolerate higher doses of metformin. -Patients on metformin doses <1500 mg/day can have their metformin doses uptitrated to =1500 mg/day, and be eligible to participate after their dose remains stable for =12 weeks, if they meet all other eligibility criteria. -Patients currently being treated with AHA in addition to metformin (including insulin) cannot be included in the study after wash-off. 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 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 or (c) Patient agrees to use an adequate method of contraception. For complete list of inclusion crtieria please refer to the protocol Extension study: 1. Patient has completed the P170 base study on double-blind study medication. 2. Parent/guardian understands the study procedures and risks involved with the study and voluntarily agrees to the patient's participation by giving informed written consent, and the patient has an age-appropriate understanding of the same to give informed written assent. If the parent/guardian is illiterate, please see Section 3.2.3.8.1 for details. Note: Patients, who are legally able to, should provide consent. 3. Patient and/or a family member or adult closely involved in the patient's daily activities (in the opinion of the investigator) will be available for telephone calls and study visits. 4. 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
Exclusion criteria
Exclusion criteria: Base study: At Visit 1 1. Patient has (1) known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was diagnosed with diabetes), 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 or positive test for ketonemia requiring immediate initiation of another antihyperglycemic agent. 3. Patient has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide. For complete list of exclusion criteria please refer to the protocol Extension study: 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
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Base study: Change from baseline in FPG Percentage of patients with A1C at goal (<7.0% as primary; <6.5% as secondary) at Week 20 Percentage of patients initiating glycemic rescue therapy ;Timepoint(s) of evaluation of this end point: Base study - Week 20 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Base and extension study Over 20 weeks (base) and over 54 weeks (extension)-assess safety and tolerability of the addition of sitagliptin (as MK-0431A) in pediatric patients (10-17 y.) with T2DM with inadequate glycemic control on metformin monotherapy Base study Pooled population ( MK-0431A P170 base study and MK-0431A XR P289 Phase A) to assess in pediatric patients (10-17 y.) with T2DM with inadequate glycemic control on metformin monotherapy 1 After 20 weeks effect of the addition of sitagliptin (as MK-0431A or MK-0431A XR) relative to placebo on A1C 2 Over 20 weeks safety and tolerability of the addition of sitagliptin (as MK-0431A or MK-0431A XR) Extension study Pooled population [MK-0431A P170(base+extension study) and MK-0431A XR P289(Phase A+B)] Over 54 weeks to assess the safety and tolerability of the addition of sitagliptin (as MK-0431A or MK-0431A XR) in pediatric patients (10-17 y.) with T2DM with inadequate glycemic control on metformin monotherapy ; Timepoint(s) of evaluation of this end point: Base study - Week 20 Extension study - week 54 ; Secondary Objective: Base study Pooled population (MK-0431A P170 base study and MK-0431A XR P289 Phase A) - to assess after 20 weeks the effect of the addition of sitagliptin (as MK-0431A or MK-0431A XR) on: 1 fasting plasma glucose (FPG); 2 proportion of patients initiating glycemic rescue therapy; 3 proportion of patients with A1C at goal (<7.0%) - all relative to placebo in pediatric patients (10-17 y.) with T2DM with inadequate glycemic control on metformin monotherapy: Extension study Pooled population [MK-0431A P170(base+extension study) and MK-0431A XR P289(Phase A+B)] - | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Venezuela, Bolivarian Republic of, Vietnam
Contacts
Public ContactGCTO Lithuania
UAB "Merck Sharp & Dohme"
Outcome results
None listed