Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

• Status: Completed
• Trial end date: 2017-08-15

Summary

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.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Glucagon; Glucagon-Like Peptide 1; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting