Comparison of glucose values and variability between TOUJEO and TRESIBA during continuous glucose monitoring in type 1 diabetes patients

Phase 1

• Conditions: Type 1 Diabetes Mellitus; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002756-91-NL
• Lead Sponsor: Sanofi Aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-16
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Participants with Type 1 Diabetes mellitus (T1DM)

Participants treated with multiple daily injections (MDI) using basal insulin analog once daily and rapid acting insulin analogs for at least one year

HbA1c = 7% (48 mmol/mol) and = 10% (86 mmol/mol) at screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 468
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

Participants not on stable dose of basal insulin analog

Participants having received Toujeo or Tresiba as basal insulin within 30 days prior to screening

Participants not using the same insulins (both basal and rapid) within 30 days prior to screening

Participants having received basal insulin dose =0.6 U/kg body weight within 30 days prior to screening

Participants having received any glucose lowering drugs (including any premixed insulins,human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening

End stage renal disease or on renal replacement treatment

Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery

Body weight change =5 kg within 3 months prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the noninferiority of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL on glycemic control and variability in participants with diabetes mellitus;Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Gluclose Monitoring (CGM)<br><br>To evaluate the safety of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL<br>;Primary end point(s): Time in glucose range - Percent (%) time in glucose range of =70 to =180 mg/dL (=3.9 to =10 mmol/L) at Week 12, obtained using continuous glucose monitoring (CGM);Timepoint(s) of evaluation of this end point: Week 12