| Outcome Measures: |
Primary: Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment, Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min)., Baseline and Month 36 | Secondary: Median Change From Baseline in the Ratio M/I After a 36-month Treatment, Baseline and Month 36|Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment, Change from baseline was calculated as the Month 18 value minus the baseline value. Insulin secretion capacity is measured in blood (blood level of insulin) and is a response of the pancreatic beta-cells to hyperglycemia induced by a glucose IV bolus, then infusion. Hyperglycemic clamp (HC) is a reference technique to evaluate the initial and the secondary phases of insulin secretion., Baseline and Month 18|Mean Change From Baseline in HbA1c at Month 36, Change from baseline was calculated as the Month 36 value minus the baseline value. HbA1c levels were measured by blood draw., Baseline and Month 36|Mean Change From Baseline in FBG at Month 36, Change from baseline was calculated as the Month 36 value minus the baseline value. FBG levels were measured by blood draw., Baseline and Month 36|Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment, Baseline and Month 36|Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment, Baseline and Month 36|Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment, Baseline and Month 36|Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment, Baseline and Month 36|Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36, Change from baseline was calculated as the Month 18 and 36 values minus the baseline value. Insulin sensitivity is measured as the quantity of glucose metabolized per unit of plasma insulin concentration., Baseline and Months 18 and 36
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