None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with MK-0893, in tablets, at a dose of 80 mg, PO, QD + MK-0893 Placebo, in tablets, PO, QD + Metformin Placebo, in tablets, PO, BID
GROUP 6 Type of group
This group will be treated with MK-0893 Placebo, in tablets, PO, QD + Metformin Placebo, in tablets, PO, BID
This scheme will be administered for 12 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has T2DM. 2. The patient is ≥ 21 and ≤ 70 years of age on the day of signing the informed consent form. 3. The patient: a) Is not receiving oral antihyperglycemic drugs for a minimum of 10 weeks, and has an HbA1c ≥ 7.0% and ≤ 11.0%. OR b) Receiving a single oral antihyperglycaemic drug, and has an HbA1c ≥ 6.5% and ≤10.0%, OR c) Receiving a combined low dose oral antihyperglycemic drug, at a dose less than or equal to 50% of the maximum recommended dose of both components, and has an HbA1c ≥ 6.5% and ≤10.0%. 4. The patient is a man, or a woman who is unlikely to conceive. 5. The patient understands the study procedures, alternative treatments available, and the risks involved in the study, and voluntarily agrees to participate by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. 2. The patient has symptomatic hyperglycemia that requires immediate initiation or addition of antihyperglycemic therapy. 3. The patient has received treatment with a PPARy agonist within the last 3 months. 4. The patient has received treatment with insulin within the last 2 months. 5. The patient has received treatment with a GLP-1 mimetic or agonist. 6. The patient has a history of hypersensitivity or contraindication to metformin. 7. The patient is in a weight loss program and is not in the maintenance phase, or the patient has received treatment with a weight-loss drug within 8 weeks of Visit 1. 8. The patient has received treatment with an investigational drug within the previous 3 months or is participating in another clinical trial. 9. The patient receives or appears to require treatment with immunosuppressive / immunomodulatory agents or the patient receives or appears to require treatment for> 14 consecutive days or Repeated cycles of pharmacological doses of corticosteroids. 10. The patient has undergone surgery within 30 days prior to Visit 1 or has planned major surgery. 11. The patient has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months, or has any of the following in the last 6 months: Acute coronary syndrome, coronary artery surgery. 12. The patient has had a stroke or TIA. 13. The patient has a cardiac status of Class I - IV. 14. The patient has a systolic blood pressure> 150 mm Hg or diastolic blood pressure> 85 mm Hg. 15. The patient suffers from a severe peripheral vascular disease. 16. The patient suffers from active liver disease, active viral hepatitis or primary biliary cirrhosis. 17. The patient suffers from active nephropathy. 18. The patient is HIV positive. 19. The patient has a clinically significant hematologic disorder. 20. The patient is under treatment for hyperthyroidism. 21. The patient has a history of malignancy. 22. The patient is a user of recreational or illicit drugs, or has had a recent history of drug addiction or alcohol abuse or drug or alcohol dependence. 23. The patient does not accept to abstain from alcohol during the 48 hours prior to each clinical visit. 24. The patient has donated blood products or has undergone a phlebotomy> 300 mL within 8 weeks of signing the informed consent, or intends to donate blood products or receive blood products within the projected duration of the study. 25. The patient is pregnant, has a positive urine pregnancy test, expects to conceive within the projected duration of the study, or is breastfeeding. 26. The patient has poor mental performance or some other reason that makes it difficult for the patient to meet the requirements of the study. 27. The patient is unlikely to comply with study procedures and respect appointments, or is planning to move during the study. 28. The patient plans to donate eggs during the study. 29. The patient has a history or current evidence of a condition, therapy, laboratory abnormality or other circumstance that could represent a risk for the patient or make his participation not the most convenient for him, could confuse the results of the study, or interfere with patient participation throughout the study. 30. The patient has a laboratory value exclu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting serum glucose level. Measure:Change with respect to the baseline in the FPG. Timepoints:Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Serum levels of glycosylated hemoglobin (HbA1c) Criterion 2: Serum glucose levels after 2 hours of oral intake. Criteria 3 and 4: Serum levels of glucose, C-peptide, insulin and proinsulin. Criterion 5: Mathematical calculation of B cell reserve and insulin reserve (HOMA-B and HOMA-IR). Criterion 6: Serum levels of Glucagon-like peptide (GLP-1). Measure:Secondary efficacy: 1) Change from baseline in HbA1c. 2) Change from baseline in glucose 2 hours postprandial (PPG). 3) Change from the baseline in the 2-hour postprandial glucose oscillation and the area under the curve for glucose, C-peptide, and insulin. 4) Change from the baseline in the proinsulin-to-insulin ratio. 5) Change with respect to the baseline in HOMA-B and HOMA-IR. 6) Change from baseline in GLP-1 levels. Timepoints:Criterion 1: Weeks 4, 8, 12 and during the discontinuation Criterion 2: Weeks 2, 4, 6, 8, 12, 15 and during the discontinuation. Criterion 3, 4 and 5: Before starting treatment, week 12 and during discontinuation. Criterion 6: Weeks 6 and 12 and during the discontinuation. ; Outcome name:Criterion 1: Medical evaluation of any unfavorable and involuntary change in the structure, function or biochemistry of the body, temporarily associated with the use of the product under investigation. Criterion 2: The weight will be measured on a calibrated digital scale. Criterion 3: Measurement of blood pressure, heart rate, respiratory rate and temperature. Criterion 4: Ambulatory device for measuring blood pressure for 24 hours. Criterion 5: Complete physical examination. Criterion 6: Panels of hematology and serum biochemistry. Criterion 7: Standard 12-lead electrocardiogram. Measure:Security: 1) Adverse events. 2) Body weight. 3) Vital signs- 4) Ambulatory blood pressure during 24 hours. 5) Physical examination. 6) Laboratory tests. 7) ECG. Timepoints:Criteria 1, 2, 3: Day 1 and weeks 2, 4, 6, 8, | 1 | — |
Countries
Australia, Austria, China, Colombia, Germany, Hungary, India, Israel, Malasya, Mexico, New Zealand, Norway, Philippines, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed