None listed
Conditions
Interventions
GROUP 1 Type of group
All patients will discontinue their antihyperglycemic agents (AHA), with the exception of metformin, provided they receive a stable dose of metfonnin> 1500 mg / day or the maximum tolerated dose for a minimum of 2 weeks before selection as part of a double or triple therapy with AHA.
After this all patients will start with MK-0478 Placebo 1 time a day every day for 1 week.
Finally, during the post-randomization phase, they will continue with MK-0478 Placebo 1 time a day every day for 24 we
Sponsors
MERCK & CO.INC., BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient suffers from type 2 diabetes and receives at least one and up to 3 oral antihyperglycemic therapies. 2. The patient is in the age range greater than or equal to 18 and less than or equal to 70 years. 3. The patient has very little chance of conceiving. 4. The patient understands the study procedures, has the will and ability to perform the daily SBGM and administer the insulin injection and its corresponding dose adjustment, and agrees to participate in the study by providing written informed consent. 5. The patient meets the criteria for the HbA1c value.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. 2. The patient is currently receiving treatment with a daily insulin therapy. 3. The patient is receiving 3 oral antihyperglycemic agents, none of which is metformin. 4. The patient has fasting TG> 600 mg / dL (6.8 mmol / L). 5. The patient has a history of allergy, intolerance or hypersensitivity to PPARalpha agonists. 6. The patient is receiving any of the following therapies for lipids: a) Niacin, ezetimibe or bile acid binding resins within 6 weeks prior to selection. b) A fibrate agent within 8 weeks prior to selection. c) Probucol within 1 year prior to selection. 7. The patient is being treated with a statin agent and does not receive a stable dose for at least 6 weeks before Visit 2. 8. The patient is participating in a weight loss program and is not in the maintenance phase. 9. The patient is receiving or is likely to need treatment with pharmacological doses of corticosteroids for 14 consecutive days or repeated cycles of these doses. 10. The patient has undergone surgery within the previous 30 days or has planned major surgery during the study. 11. The patient has received treatment with an investigational drug within 8 weeks prior to Visit 1. 12. The patient has significantly abnormal liver function. 13. The patient has a CPK value> 2 times above the ULN. 14. The patient has elevated serum creatinine. 15. The patient has abnormal TSH or evidence of hyperthyroidism or uncontrolled hypothyroidism. 16. The patient is a man whose hemoglobin is <11 g / dL. 17. The patient presents hematuria. 18. The patient has proteinuria. 19. The patient suffers from liver disease or active cholecystopathy, including primary biliary cirrhosis. 20. The patient presents with new signs or symptoms of coronary heart disease or congestive heart failure or worsening of these signs or symptoms within the last 3 months. 21. The patient has a cardiac functional condition of Class II, III or IV. 22. The patient will be taking metformin after Visit 2 and requires pharmacological treatment for CHE. 23. The patient has inadequately controlled hypertension. 24. The patient is HIV positive. 25. The patient has a clinically important hematologic disorder. 26. The patient has a positive urine pregnancy test. 27. The patient has clinically significant laboratory or ECG abnormalities. 28. The patient has a history of malignancy. 29. The patient is not willing to comply with restrictions on the consumption of alcohol. 30. The patient has a history of alcohol or drug abuse within the last 3 years. 31. The patient has any other condition or therapy that, in the opinion of the investigator, could put the patient at risk and make their participation not the most convenient for them. 32. The patient has poor mental performance or some other reason that suggests that the patient will have difficulty meeting the requirements of the study, including SBGM and insulin therapy. 33. The patient has viral hepatitis (hepatitis B or C). 34. The patient possibly suffers from type 1 diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of the daily dose of insulin needed to maintain a glucose <100 mg / dl. Measure:Primary efficiency. Timepoints:Every day until the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HBA1c and FPG Measure:Carbohydrate metabolism Timepoints:HbA1c: Weeks 0, 6, 12, 16, 20 and 24. FPG: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24 ; Outcome name:Triglycerides (TG), total cholesterol, HDL-C, non-HDL-C, apolipoprotein B, free fatty acids (FFA). Measure:Metabolism of the Lipids. Timepoints:Lipid panel: Weeks 0, 12 and 24. ; Outcome name:1) Monitoring of adverse events. 2) Clinical evaluation. 3) Laboratory evaluations (blood chemistry, urine test, pregnancy test). 4) Electrocardiogram (ECG). Measure: 487/5000 Safety of the treatment Timepoints:1) Monitoring of adverse events, clinical evaluation: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24. 2) Biochemistry tests: Weeks 0, 4, 12, 16, 24. 3) Urine test: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24. 4) Pregnancy test: Weeks 4, 7, 12, 16, 20, 24. 5) ECG: Weeks 0 and 24. | — |
Countries
Costa Rica, Mexico, New Zealand, Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed