None listed
Conditions
Interventions
50 mg LAF237 Type of group
Patients will continue with the treatment assigned during the main study LAF237 50 mg bid
Group name:metformin Type of group
Patients will continue with the treatment assigned during the main study with metformin up to 1000 mg bid.
Sponsors
NOVARTIS PHARMACEUTICALS CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: Written informed consent to participate in the extension; ability to meet all the requirements of the study.
Exclusion criteria
Exclusion criteria: Premature discontinuation of the core phase of the study. Concomitant medical conditions that interfere with the interpretation of the study results. According to the definition of the core phase protocol; lack of compliance with the core phase of the protocol: patients that may be unreliable, and patients that the researcher considers unfit for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c, fasting plasma glucose, beta cell function (proinsulin in proinsulin / fasting insulin, HOMA B), insulin resistance (fasting insulin, HOMA IR), body weight, fasting lipids (trigiiceridos, total cholesterol, LDL calculated, HDL, calculated VLDL, non-HDL cholesterol), and prandial glucose, insulin and C-peptide after an overload test with liquid food. Measure:Long-term efficacy of LAF237 compared to metformin. Timepoints:104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c, fasting plasma glucose. Measure:Long-term efficacy of LAF237 compared to metformin evaluating the effect on HbAic after 104 weeks of treatment compared to the end-of-phase core values of the study (Week 52). Timepoints:104 week | — |
Countries
Peru, United States
Outcome results
None listed