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A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin

NCT02967211 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change

Secondary Objectives:

* To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change.
* To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
* Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group).
* Change in fasting plasma glucose (FPG).
* Change in body weight.
* Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc).
* Change in hypoglycemic control subscale (HCS).
* Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

insulin glargine (U300)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

insulin glargine (U100)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

NPH insulin

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

insulin detemir

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

insulin degludec

Pharmaceutical form: solution Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-21
Primary Completion
2017-10-20
Completion
2017-10-20

Countries

  • Brazil
  • Finland
  • France
  • Greece
  • Ireland
  • Italy
  • Romania
  • Spain
  • Switzerland
  • 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 NCT02967211 on ClinicalTrials.gov