MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0767 ADDED TO INSULIN THERAPY IN PATIENTS WITH DIABETES MELLITUS TYPE 2 CONTROLLED INADECUATELY.
Phase 1
- Conditions
- E119-E119 Non-insulin-dependent diabetes mellitus, without complicationsNon-insulin-dependent diabetes mellitus, without complications
- Registration Number
- PER-045-03
- Lead Sponsor
- MERCK & CO.INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:GLUCOSE: FPG, HbAic and C peptide; total daily insulin dose; proportion of patients that meet the glycemic objectives of the ADA.<br><br>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.<br>Measure:Efficiency of MK-0767<br>Timepoints:12 hours<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Monitoring of adverse events, clinical evaluation (including vital signs / body weight, waist measurement, BMI, physical examination), laboratory evaluation (including<br>AST, ALT, CPK, chemistry, hematology, urine dipstick test / urine microscopy, urine pregnancy test), and electrocardiography (ECG).<br><br>Measure:Safety measurement<br><br>Timepoints:weekly<br>