None listed
Conditions
Interventions
Group 1 Type of group
MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥
1500 mg/day and ≤
2550 mg/day (or ≤
Group 2 Type of group
Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥
3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • The patient has type 2 diabetes mellitus (T2DM). • The patient is> 18 and 20 kg / m2 and 7.5% and 7.0% and <10.5%. • The patient is a man or a woman with no probability of conceiving • The patient understands the study procedures, the available alternative treatments and the risks involved in the study, and agrees to voluntarily participate in the study by granting their written informed consent.
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 researcher as a patient who probably has type 1 diabetes, confirmed with a C peptide 14 consecutive days or repeated cycles of pharmacological doses of systemic corticosteroids (oral, injectable / parenteral) or ocular during the study. • The patient has undergone a surgical procedure within 30 days prior to the signing of the informed consent or has planned major surgery during the study. • The patient has new or progressive signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months • The patient has a Class II - IV heart condition according to the NYHA (New York Cardiology Association) (see Annex 6.2) or has severe peripheral vascular disease (eg, manifested by claudication with minimal activity, an ischemic ulcer slow closing, or illness that probably requires intervention such as bypass or angioplasty). • The patient has poorly controlled hypertension, defined as a systolic blood pressure> 160 mmHg or a diastolic blood pressure> 90 mmHg and it is not considered likely that the blood pressure is below these limits for Visit 4 / Day -1 with an adjustment of antihypertensive regimen. • The patient has a history of active liver disease (other than non-alcoholic liver steatosis), which includes chronic active hepatitis B or C (evaluated by medical history), cirrhosis or symptomatic disease of the gallbladder. • The patient is HIV positive (based on medical history evaluation). • The patient has a clinically significant hematologic disorder (eg, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). • The patient is currently treated with antithyroid drugs or radioactive iodine for hyperthyroidism. • The patient has a history of malignant disease 5 years without documentation of remission / cure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The weighted mean was used to avoid over-representation of post-meal glucose values. Measure:Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose Timepoints:Baseline and Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Glucose measurement by laboratory tests during the study Measure:Change from baseline in glucose value after a 2-hour meal (2-hour PMG) for each meal in Week 6. Timepoints:6 weeks ; Outcome name:Fasting plasma glucose measurement by laboratory tests during the study Measure:Change from baseline in fasting plasma glucose (FPG) in Week 6. Timepoints:Week 6 ; Outcome name:HOMA-IR = [(fasting insulin in mcIU / mL) x (FPG in mg / dL) /(22.5x 18)] HOMA-p = [20x (fasting insulin in mcrU / mL) / {(FPG in mg / dL) / 18 - 3.5}] QUICKI = [l / {log10 (fasting insulin in mcIU / mL) + log (FPG in mg / dL)}] Measure:Change from baseline in Week 6 on fasting insulin, HOMA-IR, HOMA-p, QUICKI. Timepoints:Week 6 ; Outcome name:All AUC values will be calculated using blood sample data from 0 to 120 minutes after the start of the meal and using the trapezoid rule. Measure:hange from baseline in Week 6 in the total AUC and AUC deviation values (incremental AUC over the level at the beginning of the meal) of insulin after the morning meal, AUC of total glucose after the middle meals Day and night, AUC deviation glucose after each of the three meals. Timepoints:Week 6 ; Outcome name:Total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C ] and triglycerides [TG] measurement by laboratory tests during the study Measure:Percent change from baseline in Week 6 for endpoints measured or derived from the lipid panel (ie, total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C ] and triglycerides [TG]). Timepoints:Week 6 | — |
Countries
Australia, Canada, Colombia, Denmark, Estonia, Finland, India, Ireland, Italy, Malasya, Norway, Poland, Russian Federation, Sweden, Taiwan, United States
Contacts
Public Contactstela lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed