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-IE
• Lead Sponsor: sanofi-aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-13
• Last Update Posted: 11 December 2017

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, glinides, alpha glucosidase inhibitors) and with or without glucagon-like peptide-1 (GLP-1) receptor agonist, and eligible to basal insulin treatment, per investigator's judgment.
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,
• Use of any product containing insulin occurring within 3 months prior to the time of screening,
• 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,
• Hypersensitivity to insulin glargine or Toujeo excipients,
• Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, studycoordinator, other staff or relative thereof directly involved in the conduct of the protocol,
• 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