Type 2 Diabetes Mellitus
Conditions
Interventions
Study setting: specialist tertiary care diabetes centres (Diabetic and Endocrinology Units of NHSL, Colombo South Teaching Hospital and Teaching Hospital Kandy)
Consenting participants will be random
Sponsors
Merck Sharp and Dohme Corp
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects between the age of 10 to 17 years on day of signing informed consent with randomization to occur prior to 18th birthday. 2. Diagnosed Type 2 Diabetes Mellitus (T2DM) 3. Subject has not received treatment with insulin for at least 12 weeks prior to the screening visit 4. Hb A1C ?6.5% and ?10.0% on a stable dose of metformin immediate release or extended release (?1500 mg/day, for ?12 weeks) 5. Participant has a family member or adult closely involved in the daily activities and will participate in the subject's treatment and study protocol (i.e., available for telephone calls, study visits and administration of study medication as needed). 6. Informed consent from parent or guardian
Exclusion criteria
Exclusion criteria: 1. Known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was diagnosed with diabetes). 2. Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes. 3. Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent. 4.Subject has previously taken a DPP-4 inhibitor or GLP-1 receptor agonist 5. Initiation of chronic treatment with a medication known to cause weight gain OR weight loss 6. Current participation, or has participated within the prior 12 weeks, in a study in which the subject received an investigational compound or used an investigational device or is not willing to refrain from participating in another interventional study. 7. Currently on or likely to require treatment with >14 consecutive days or repeated courses of pharmacologic doses of corticosteroids 8. Undergone a surgical procedure within 4 weeks prior to signing informed consent or has major surgery planned during the study. 9. History of congenital heart disease or cardiovascular disease other than hypertension. 10. Visit 1 systolic or diastolic blood pressure of >95th percentile for age, height percentile and gender and is not considered likely to have values 10% of estimated total blood volume within 8 weeks of signing informed consent, or intends to donate blood products or receive blood products within the projected duration of the study. 22. Known pregnancy, positive urine pregnancy test or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug. 23. Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 24. History or current evidence of any condition, therapy, laboratory abnormality or other circumstanc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hemoglobin A1c (A1C) 2. Symptomatic adverse events of hypoglycemia 3. Selected gastrointestinal (GI) events (nausea, vomiting, abdominal pain or discomfort, and diarrhea) [At baseline, week 20 and week 54] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change from baseline in A1C 2) Proportion of subjects meeting A1C goals (<7.0%, <6.5 3) Change from baseline in FPG 4) Proportion of subjects initiating glycemic rescue therapy 5) Proportion of subjects initiating insulin glargine [1) At baseline and week 54 2) At baseline, week 20 and week 54 3 At baseline, week 20 and week 54 4) At the end of week 20 5) Between week 20 – week 54 ] | — |
Countries
Australia,Brazil,Bulgaria,Canada,Chile,Colombia,Costa Rica,Czech Republic,Denmark,Georgia,Greece,Honduras,Hungary,India,Israel,Italy,Mexico,Moldova, Republic of,New Zealand,Panama,Philippines,Russian
Contacts
Public ContactDr. Noel Somasundaram
Consultant Endocrinologist
Outcome results
None listed