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Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

NCT04075513 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2022-11-14

Study results available
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Summary

Primary Objective:

To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (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 Glucose Monitoring.

To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100 U/ml.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Background therapy: Rapid acting insulin analogs

Route of administration: SC injection

DRUG

Insulin degludec, 100U/ml

Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection

DRUG

Insulin glargine, 300 U/ml

Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2021-09-16
Completion
2021-09-16
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Germany
  • Hungary
  • Netherlands
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075513 on ClinicalTrials.gov