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P021

Peptide 021, GLXC-21260

Quick Stats
Studies 37
Trials 57
Completed PHASE4 INTERVENTIONAL NCT02688933

A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Primary Objective: To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus. Secondary Objective: To demonstrate that treatment with HOE901-U300 compared to Lantus provides: * Lower incidence rate of nocturnal symptomatic hypoglycemia; * Better glucose control coverage during the last hours of CGM before next basal-insulin dosing; * Less variability in CGM profile.

Detailed Description

The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.

Interventions

Name: HOE901-U300 (Insulin Glargine 300 U/ml)
Type: DRUG
Description: Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.
Name: Lantus (Insulin Glargine 100 U/ml)
Type: DRUG
Description: Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.
Name: Mandated back ground therapy
Type: DRUG
Description: Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Primary Outcomes

Measure: Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM
TimeFrame: During Week 15 and/or 16
Description: The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).

Trial Information

NCT ID

NCT02688933

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Sanofi

Last Updated

December 15, 2025