None listed
Conditions
Interventions
100 mg MK- 0431 Type of group
100 mg MK-0431 is administered once a day before breakfast.
Group name:Placebo Type of group
Placebo of 100 mg MK-0431 is administered once a day before breakfast.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. The patient has type 2 diabetes mellitus. b. The patient is> 18 years of age. c. The patient understands the study procedures and agrees to participate in the study by providing written informed consent. d. The patient is not pregnant or breastfeeding and does not plan to become pregnant during the course of the study or during the post-study follow-up period.
Exclusion criteria
Exclusion criteria: a. The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. b. The patient required insulin within the previous 8 weeks. c. The patient began a treatment with a medication to lose weight within the previous 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c Measure:Measurement of drug efficacy Timepoints:week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The collection of adverse events, physical examination, vital signs and body weight. laboratory will include blood chemistry (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase), hematology (including complete blood count, differential, and absolute neutrophil count), urinalysis, urine pregnancy test (performed on women potentially fertile), an ECG will also be performed. Measure:Measurement of drug safety Timepoints:week 24 | — |
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed