None listed
Conditions
Interventions
5 mg MK-0767 of placebo will be administered in addition to the usual treatment.
Group name:3,5 mg MK-0767 Type of group
3,5 mg MK-0767 will be administered in addition to the usual treatment.
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes with inadequate glycemic control in stable monotherapy with insulin or stable therapy with insulin in combination with an oral antidiabetic agent that meet the following criteria will be incorporated for enrollment in the study. Men and women not pregnant. Be> 21 years old Understand the study procedures and agree to participate in the study by providing written informed consent.
Exclusion criteria
Exclusion criteria: The participation in the study of those individuals who meet any of the following criteria in Visit 1 / Week 7 is excluded (unless otherwise indicated). All laboratory measurements should be carried out after an overnight fast> 12 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:GLUCOSE: FPG, HbAic and C peptide; total daily insulin dose; proportion of patients that meet the glycemic objectives of the ADA. LIPIDS: total cholesterol, triglycerides and free fatty acids; no HDL-C, LDL-C and HDL-C; Total cholesterol / HDL-C and LDLC / HDL-C ratio; proportion of patients that meet the objectives of the NCEP ATP III; Apolipoproteins A-I and B. Measure:Efficiency of MK-0767 Timepoints:12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Monitoring of adverse events, clinical evaluation (including vital signs / body weight, waist measurement, BMI, physical examination), laboratory evaluation (including AST, ALT, CPK, chemistry, hematology, urine dipstick test / urine microscopy, urine pregnancy test), and electrocardiography (ECG). Measure:Safety measurement Timepoints:weekly | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed