A Real World” Trial to determine efficacy and health outcomes of TOUJEO compared to standard of care” basal insulins in insulin naïve patients intiating insuli

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001831-18-FR
• Lead Sponsor: sanofi-aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

Patients with type 2 diabetes (T2DM) insufficiently controlled (HbA1c >7%) with current (= 6 months) standard of care with oral agents (metformin, sulfonylurea, thiazolidinedione, dipeptidyl peptidase-4 [DPP-4] inhibitor, sodium-glucose cotransporter 2 [SGLT-2] inhibitor, glinide), and with or without glucagon-like peptide-1 (GLP-1) receptor agonist.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 230

Exclusion Criteria

• HbA1c =7%, no upper bound,
• Age <18 years,
• Type 1 diabetes mellitus,
• Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study,
• Use of any product containing insulin since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization (insulin glargine, Lantus, Levemir, Toujeo, Tresiba, Humulin or biosimilar, Humalog®, Novolog®, Apidra®, Afrezza®, pre-mix insulin, or other insulin products which become available),
• Use of any product containing insulin occurring within 3 months prior to the time of screening (insulin glargine, Lantus, Levemir, Toujeo, Tresiba, Humulin,or biosimilar, Humalog, Novolog, Apidra, Afrezza, pre-mix insulin, or other products which become available),
• Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening,
.• All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products,
• Pregnancy or lactation,
• Women of childbearing potential with no effective contraceptive method.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified