A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the effect and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual β-cell function at baseline.

Recent onset Type 1 Diabetes

- Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Primary endpoint. Time frame: Month 6].

Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Time frame: month 12, 18 and 24]., Change in HbA1c from baseline [Time frame: Month 6, 12, 18 and 24]., Time in range (TIR) by Continuous Glucose Monitoring (CGM) [Time frame: Month 6, 12, 18, 24]., Proportion of patients with HbA1c <7% who did not experience severe hypoglycemic events during treatment [Time frame: Month 6, 12, 18 and 24]., Average (previous 3 days) daily insulin requirement (IU/kg/day) [Time frame: Month 6, 12, 18 and 24]., Proportion of patients with HbA1c <7% and daily insulin requirement <0.5 (IU/kg/day) [Time frame: Month 6, 12, 18 and 24]., Additional Glucose Variability Indices derived from CGM (glucose AUC outside the target range of 70 – 180 mg/dL, 2-hour postprandial glucose (PPG), Mean Amplitude Glycemic Excursions (MAGE), continuous overall net glycemic action (CONGA)-n, Mean Of the Daily Differences (MODD), and mean daily blood glucose, SD (Standard Deviation). [Time frame: Month 6, 12, 18 and 24]., Number of self-reported episodes of severe hypoglycemia [Time frame: Month 6, 12, 18 and 24]., Percentage of patients not requiring insulin therapy [Time frame: Month 6, 12, 18 and 24], Estimated Glucose Disposal Rate (eGDR) [Time frame: Month 6, 12, 18 and 24].

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Belgium, Germany, Italy