None listed
Conditions
Interventions
100 mg MK-0431 Type of group
100 mg MK-0431 will be given once a day before the morning meal.
Group name:Placebo Type of group
Placebo of MK-0431 will be given once a day before the morning meal.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. The patient suffers from type 2 diabetes mellitus (T2DM). b. The patient is> 18 to <75 years of age. c. The patient understands the study procedures and agrees to participate in the study by giving 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 follow-up period after the study.
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 a previous period of 8 weeks. c. The patient is in a weight loss program and is not in the maintenance phase. d. The patient began a treatment with a medication to lose weight within a previous period of 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c Measure:Measurement of drug efficacy Timepoints:14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:the collection of adverse events, physical examination, vital signs and body weight. Laboratory safety studies will include a blood chemistry (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase, and creatine phosphokinase [CPK], hematology (including whole blood count [CBC], differential, and absolute neutrophil count), urinalysis and urine pregnancy test (performed on potentially fertile women) An ECO will be performed and read at the central laboratory. Measure:Drug safety measurements Timepoints:14 day | — |
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed