None listed
Conditions
Interventions
Group 1 Type of group
MK-0941 10 mg orally for 14 weeks and then modified to 40 mg for 40 weeks
Group name:Group 5 Type of group
Placebo orally administered for 54 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
21 Years to 70 Years
Inclusion criteria
Inclusion criteria: • The patient has type 2 diabetes mellitus (T2DM). • The patient is> 21 and 15 units / day, either alone or in combination with a metformin monotherapy at a dose> 1500 mg / day, for a minimum of 6 weeks, and has an HbA1c > 7.5% and 7.5% and 15 units / day) • The patient has a body mass index (BMI)> 20 kg / m2 and 7.5% and 85% compliance during the simple blind transition period as measured by the count of tablets carried out on the site.
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. Or the patient possibly suffers from type 1 diabetes according to the researcher´s evaluation confirmed with a peptide level C 14 consecutive days or repeated courses of pharmacological doses of systemic corticosteroids (oral) , injectable / parenteral) or ocular, during the study. • The patient has undergone surgery within 30 days prior to Visit 1 / Screening Visit or has planned major surgery. • The patient presents new signs or symptoms of coronary heart disease or congestive heart failure, or worsening of them, within the last 3 months, or has suffered from any of the following disorders in the last 6 months: Acute coronary syndrome (for example , MI or unstable angina), coronary artery surgery (for example, CABG or PTCA), cerebrovascular accident or TIA (transient ischemic attack) • The patient has a Class II-IV cardiac condition established by NYHA (refer to Appendix 6.5) or has a severe peripheral vascular disease (eg, manifested by claudication with minimal activity, an ischemic ulcer that does not heal, or a disease that probably requires intervention as with a bypass or angioplasty). • The patient has a systolic blood pressure> 165 mm Hg or diastolic blood pressure> 95 mm Hg and blood pressure is not considered likely to fall below these limits at Visit 5 / Day 1 with an adjustment of the antihypertensive regimen. • The patient suffers from chronic myopathy, or a progressive neuromuscular or neuromuscular disorder (eg, multiple sclerosis or polymyositis). • The patient has nephropathy (ie, nephrotic syndrome or glomerulonephritis). • The patient suffers from active liver disease (different from nonalcoholic hepatic steatosis), active viral hepatitis (Hepatitis B or chronic Hepatitis C) according to the evaluation of the medical history, cirrhosis, or active cholecystopathy, including primary biliary cirrhosis. • The patient is HIV positive (based on the evaluati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HbA1c levels during the study. Measure:Change from baseline in HbA1c in Week 14 (Phase A) and in Week 54 (Phase B). Timepoints:Week 14 (Phase A) and in Week 54 (Phase B) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of glucose levels 2 hours postprandial during the study Measure:Change from baseline in glucose 2 hours postprandial in Week 14 (Phase A) and in Week 54 (Phase B). Timepoints:Week 14 (Phase A) and in Week 54 (Phase B). ; Outcome name:Measurement of plasma glucose levels by laboratory tests during the study. Measure:Change from baseline in fasting plasma glucose (FPG) in Week 14 (Phase A) and in Week 54 (Phase B). Timepoints:Week 14 (Phase A) and in Week 54 (Phase B). | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed