None listed
Conditions
Interventions
Group 1 Type of group
2 tablets of a dose of 25 mg of MK-0431 for 12 weeks
Group name:Group 2 Type of group
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has type 2 diabetes mellitus. • The patient has moderate, severe or terminal renal insufficiency, as indicated by a yes response to one or more of the following statements: 1) Creatinine clearance> 30 to 18 years of age. • The patient understands the study procedures and agrees to participate in it by providing written informed consent • The patient is not pregnant or nursing and does not plan to become pregnant during the course of the study and the post-study follow-up period. • The patient is a man, or a woman who is highly unlikely to conceive, as indicated by, at least, a yes answer to the following questions: 1) The patient is a man 2) The patient is a surgically sterilized woman 3) The patient is a post-menopausal woman> 45 years of age who has stopped menstruating> 2 years 4) The patient is an unsterile pre-menopausal woman who agrees to use 2 contraceptive methods adequate barrier to prevent pregnancy or agree to abstain from having heterosexual intercourse during the study from Visit 1 and for 14 days after the last dose of the study medication (Refer to Section LE 11.a. for a description of accepted contraceptive methods). • The patient meets one of the following criteria as indicated by a yes response: 1) The patient is not currently receiving an antihyperglycemic agent (out of therapy for> 8 weeks), and has an HbA1c> 6.5% and 10% at the Screening Visit 3) The patient is currently receiving monotherapy with an antihyperglycemic agent (or low dose oral combination therapy [ie, 6.5% and 75% (as measured by tablet count) with respect to placebo treatment during transition
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. • The patient required insulin within the previous 8 weeks. • The patient is following a weight loss program and is not in the maintenance phase. • The patient began taking a medicine to lose weight (for example, orlistat or sibutramine) within the previous 8 weeks. • The patient is receiving or is likely to require pharmacological doses of corticosteroids for> 14 consecutive days or during repeated cycles. • The patient is taking an excluded medication as indicated by a s1 response to one of the following statements: 1) The patient is taking an immunosuppressive / immunomodulatory agent (eg, cyclosporine, methotrexate, etanercept) 2) The patient you are taking digoxin or another cardiac glycoside. • The patient has undergone surgery that required general anesthesia within the previous 30 days or the patient has a scheduled surgery. Note: Patients who have a scheduled minor surgery can enroll after approval of the Merck medical monitor. • The patient has received treatment with an investigational drug within the previous 8 weeks. • The patient has an acute or rapidly progressive nephropathy, or has a history of kidney transplantation. • The patient has an ALT or AST> 2.0 times the upper limit of normal (ULN). • The patient has a level of triglycerides (TG)> 600 mg / dL (6.78 mmol / L) and the researcher considers that it is unlikely that he will respond to the diet / exercises and / or medication to avoid exceeding the level of TG> 600 mg / dL (6.78 mmol / L) at Visit 3. • The patient has a TSH 15 pU / mL. • The patient has a TSH> 6 pU / mL but 6 pU / mL at Visit 3 / Week -2. Note: If thyroid hormone replacement therapy is initiated or adjusted due to a TSH level> 6 pU / mL but <15 pU / mL, the dose of thyroid hormone replacement therapy should remain stable for a minimum of 5 weeks. weeks before its repetition in Visit 3 / Week -2. • The patient suffers from cirrhosis, active liver disease (different from fatty liver), or symptomatic active cholecystopathy. • The patient suffers from chronic myopathy, or a progressive neuromuscular or neuromuscular disorder (eg, multiple sclerosis or polymyositis). • The patient has one 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 PICA). • Worsening of congestive heart failure (eg, worsening of symptoms or increase in drug therapy). • Stroke or transient ischemic neurological disorder. • The patient presents new signs or symptoms of coronary heart disease, or worsening thereof, in the last 3 months. • The patient suffers from a severe peripheral vascular disease (for example, manifested by claudication with minimal activity, ischemic ulcer that does not heal, or disease that probably requires surgery, such as a bypass or angioplasty). • The patient is HIV positive (according to the medical history evaluation). • The patient has a clinically important hematologic disorder (for example, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). Note: Patients suffering from chronic and stable anemia, in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:They will be evaluated by reviewing all relevant safety parameters, including adverse events, laboratory values, vital signs, body weight and ECG. Measure:Safety and tolerability of MK-0431 Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:They will be evaluated by reviewing all relevant safety parameters, including adverse events, laboratory values, vital signs, body weight and ECG. Measure:Safety and tolerability of MK-0431 Timepoints:Week 54 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed