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Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

NCT03703869 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4589

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary Objective:

Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).

Secondary Objectives:

* Assess effectiveness in achieving glycemic goal measured by HbA1c;
* Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
* Assess requirement for intensification of therapy by additional antidiabetics.
* Assess incidence of hypoglycemia;
* Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
* Assess change in body weight.

Conditions

Interventions

DRUG

Insulin glargine (U300)

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2019-06-28
Completion
2020-02-24

Countries

  • Colombia
  • Egypt
  • India
  • Indonesia
  • Israel
  • Jordan
  • Kuwait
  • Lebanon
  • Mexico
  • Peru
  • Philippines
  • Russia
  • Saudi Arabia
  • Singapore
  • Taiwan
  • Thailand
  • Ukraine
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Diseases
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 NCT03703869 on ClinicalTrials.gov