A Study Comparing the Effectiveness and Safety of the Morning Injection of Toujeo versus Lantus in Patients with Type 1 Diabetes Mellitus

Overview

About this study

The purpose of this study is to demonstrate that a morning injection of Toujeo compared to Lantus will provide better glycemic control, as shown  by Continuous Glucose Monitoring (CGM), in adult patients with type 1 diabetes mellitus.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Adult patients (male and female) with type 1 diabetes mellitus (T1DM)
  • Signed written informed consent

Exclusion Criteria

  • Age <18 years or >70 years
  • Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at visit 1
  • Glycated hemoglobin (HbA1c) <7.0% or >9.0% via central lab test at visit 1
  • Experienced none or only 1 episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association [ADA] classification) during the past month prior to screening
  • Experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening
  • Received less than 1 year treatment with basal plus mealtime insulin
  • Used any basal insulins other than Lantus in the past 3 months before screening
  • Requires >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 half-lives, 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
  • Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5-point SMPG records by the end of screening
  • Other considerations relevant to a patient's potential participation in a clinical trial

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Adrian Vella, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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