Type II Diabetes
Conditions
Sponsors
Novartis Pharmaceuticals UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the extension study. 2. Ability to comply with all study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Premature discontinuation from the core study. 2. Concomitant medical conditions that interfere with the interpretation of study results as defined in the core protocol. 3. Failure to comply with the core study protocol. 4. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1.assess long-term efficacy of LAF237 compared to metformin by evaluating effect on HbA1c after 104 wks of treatment as compared to the end of the core study 2.assess long-term efficacy of LAF237 compared to metformin by evaluating the effect on FPG after 104 weeks of treatment as compared to the baseline and compared to the end of the core study 3.assess mechanism of action of LAF237 compared to metformin by evaluating effect on beta-cell function (indexed by fasting proinsulin concentration, fasting proinsulin/insulin ratio and HOMA B) and insulin resistance (indexed by the fasting insulin concentration and HOMA IR) after 104 wks of treatment as compared to baseline and compared to end of core study 4.assess ancillary clinical benefits of LAF237 compared to metformin by evaluating effect on fasting plasma lipid profiles and body weight after 104 wks of treatment as compared to the baseline and compared to the end of core study ;Primary end point(s): primary efficacy variable is change from baseline in HbA1c at Week 104 or at the final visit with HbA1c measurement for those patients who do not have a Week 104 HbA1c measurement (the last observation carried forward (LOCF) approach). ;Main Objective: Primary 1. To assess the long-term safety of LAF237 compared to metformin during 104 weeks of treatment. 2. To assess the long-term efficacy of LAF237 compared to metformin by evaluating the effect on HbA1c after 104 weeks of treatment as compared to the baseline. | — |
Countries
Spain, United Kingdom
Outcome results
None listed