CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 929 enrolled
Drug / intervention
Insulin glargine, 300U/mL +2 moredrug
Likely dose
Insulin glargine, 300U/mL 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02738151
NCT02738151Phase 4Completed
CompareCT.gov

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

Sanofi·interventional·Posted Apr 14, 2016·Updated Sep 14, 2018

In Brief

A Phase 4 clinical trial evaluating Insulin glargine, 300U/mL, Insulin degludec, 100 U/mL, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 929 participants across 158 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBulgaria, Croatia, Czechia, Denmark, France, Greece, Hungary, Israel, Italy, Romania, Serbia, Slovakia, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 14, 2016
Enrollment StartMay 19, 2016
Primary CompletionAug 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.2 years ago

Interventions

Insulin glargine, 300U/mLdrug

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).

Insulin degludec, 100 U/mLdrug

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L). Route of administration: subcutaneous

Non-insulin anti-diabetic treatmentdrug

Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.