None listed
Conditions
Interventions
L-410198 Type of group
Patients will be assigned in 6 groups. The arm of L-410198 of 2.5 mg / day and which were not changed at the dose of 5 mg / day in the base study will be reassigned to receive L-410198 of 5 mg / day. Patients who were assigned to L-410198 at 5 mg / day or pioglitazone at 30 mg / day in the baseline study will continue to receive the same therapy in this extension study and, if necessary, will initiate salvage therapy with metformin (from 500 to 2000 mg / day) if HbAic is> 8.0%.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. End the initial double-blind study. 2. Have met> 75% of study medication during the double-blind period of the baseline study. 3. Understanding of study procedures and agreement to participate in the study granting written informed consent.
Exclusion criteria
Exclusion criteria: -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation (physical examination including evaluation of weight, waist circumference, vital signs, electrocardiography and adverse events). Laboratory evaluation of FPG, HbA1c, total triglycerides, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatine. Measure:Safety profile and tolerability of the treatment with L-410198 of 5 mg / day. Timepoints:4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting plasma glucose Hemoglobin A1c Indices of insulin sensitivity Measure:Calculate the effects of L-410198 of 5 mg / day and pioglitazone of 30 mg / day on the glycemic control measures (Fasting Plasma Glucose, Hemoglobin A1c and in the insulin sensitivity indexes (based on glucose measurements in fasting and insulin) Timepoints:4 week | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed