None listed
Conditions
Interventions
100 mg de MK-0431 Type of group
100 mg of MK-0431 oral tablets are given fasting once a day.
Group name:placebo Type of group
Oral placebo tablets of MK-0431 are administered once a day on an empty fasting
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 between> 18 and <78 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 needed insulin within the previous 8 weeks. c. The patient is in a program to lose weight and is not in the maintenance phase. d. The patient started a therapy with medication to lose weight.
Design outcomes
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 and urine pregnancy test. Measure:measuring the safety of the drug Timepoints:24 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c Measure:Measurement of drug efficacy Timepoints:24 weeks | — |
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed