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

  • STATUS
    Recruiting
  • sponsor
    Sanofi-Aventis
Updated on 25 March 2021

Summary

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

Description

Primary objective:
To demonstrate that morning injection of Toujeo compared to Lantus will provide better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult patients with type 1 diabetes mellitus.

Secondary objective(s):
To demonstrate that treatment with Toujeo compared to Lantus will provide

  • 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.

Details
Condition Diabetes Mellitus, Type 1
Clinical Study IdentifierTX144418
SponsorSanofi-Aventis
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients (male and female) with type 1 diabetes mellitus
Signed written informed consent

Exclusion Criteria

Age <18 years or >70 years
Fasting c-peptide ≥0.3nmol/l as per source document or central lab test at Visit 1
HbA1c <7.0% or >9.0% via central lab test at Visit 1
Patients who experienced none or only 1 episode of documented symptomatic and/or severe hypoglycemia (as per the ADA classification) during the past month prior to screening
Patients who experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening
Patients receiving less than 1 year treatment with basal plus mealtime insulin
Using any basal insulins other than Lantus in the past 3 months before screening
Requiring >80 U/day Lantus and/or not on stable Lantus dose (± 20% total dose) within 30 days prior to screening
Using fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening
Using human regular insulin as mealtime insulin within 30 days prior to screening
Using an insulin pump during the last 6 months before screening
History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period
Pregnant or breast-feeding women or planning pregnancy during the duration of the study
Use of any other investigational drug(s) within 1 month or 5 halflives, whichever is longer prior to screening
Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening
Non-compliance with SMPG performance evidenced by failure to demonstrate at least 5 days of 5-point SMPG records by the end of screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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