None listed
Conditions
Interventions
Group 1 Type of group
2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
Group name:Group 3 Type of group
2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • The patient has type 2 diabetes mellitus (T2DM). • The patient´s age is> 18 and 27 kg / m2 and 12 weeks), and on Visit 1 / Selection Visit has AIC> 7% and 130 mg / dL (7.2 mmol / L) and 85% with respect to the study drug during the transition with placebo in simple blind (as determined by capsule count). • The patient complies with the diet and exercises during the transition period. • The patient has successfully completed the 24-hour home procedures, which include consuming> 50% of each meal based on caloric content.
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or the patient is being evaluated by the investigator as a possible patient with type 1 diabetes confirmed with a C-peptide value 160 mm Hg or diastolic blood pressure> 90 mm Hg and the blood pressure is not considered likely to decrease below these limits at Visit 3 / Week 2 with an adjustment in the antihypertensive drug. • The patient is HIV positive (as assessed by the medical history). • The patient is currently being treated for hyperthyroidism. • The patient suffers from a clinically important hematologic disorder (for example, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). • The patient has a history of malignant disease 5 years before signing informed consent should not present evidence of disease. • The patient has a history of macular edema or vitreous hemorrhage. • The patient has a recent history (ie, in the last 2 weeks) of eye infection or other inflammatory eye or conjunctive condition, including uveitis or scleritis. • The patient has a history of wearing conta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored. Measure:Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 Timepoints:Baseline and Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of body weight during the study. Measure:Change from baseline in body weight. Timepoints:Week 4 ; Outcome name:Laboratory values that exceed the predefined exchange limits will be evaluated. Measure:Change from baseline in fasting insulin. Timepoints:Week 4 ; Outcome name:Laboratory values that exceed the predefined exchange limits will be evaluated. Measure:Change from baseline in insulin and in post-pandrial glucose of 2 hours, insulin and post-pandrial incremental glucose of 2 hours (above the level at the beginning of the morning meal). Timepoints:4 weeks ; Outcome name:Laboratory values that exceed the predefined exchange limits will be evaluated. Measure:Change with respect to the baseline in the total AUC and the deviation values of the AUC (incremental AUC over the level at the beginning of the morning meal) of glucose and insulin during the 2 post-pandial hours. Timepoints:4 weeks ; Outcome name:Laboratory values that exceed the predefined exchange limits will be evaluated. Measure:Change with respect to baseline in the proportion of insulin AUC with respect to glucose AUC during the 2 post-pandial hours. Timepoints:Week 4 ; Outcome name:Laboratory values that exceed the predefined exchange limits will be evaluated. Measure:Percentage change with respect to baseline in plasma triglycerides (TG), LDLC, VLDL, HDL-C, Non HDL-C, proportion of TG / HDL-C and total cholesterol. Timepoints:Week 4 | — |
Countries
Colombia, Lithuania, Mexico, Norway, Peru, Poland, United States
Contacts
Public Contactstela lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed