Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
Primary Objective:
To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated
hemoglobin (HbA1c) change from Baseline to Week 24.
Secondary Objectives:
Change From Baseline in HbA1c to Week 12
To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12
and week 24 on:
- Change in Fasting plasma glucose (FPG);
- Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG
profile;
- Percentage of participants reaching HbA1c targets <7% or ≤6.5%;
- Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or
confirmed hypoglycemia
- Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes
Association (ADA) category of hypoglycemia.
To assess the safety in each treatment group.
To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).
Percentage of participants requiring rescue therapy.
The maximum study duration per participant was approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period (including 12 weeks active titration), and a 7-day posttreatment safety follow-up period. ;
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