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.
- Conditions
- Type 2 diabetes mellitusMedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-001832-39-GB
- Lead Sponsor
- sanofi-aventis Groupe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 609
• Patients with type 2 diabetes insufficiently controlled (HbA1c >7%) with current (= 6 months) standard of care” basal insulin therapy (including Lantus insulin glargine U100, Levemir, NPH or Tresiba) with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, alpha glucosidase inhibitors) and with or without use of a GLP-1 receptor agonist,
• Fasting plasma glucose (FPG) >130 mg/dL (7.2 mmol/L),
• Adult patients who have signed an Informed Consent Form (ICF) and privacy form(s).
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
• 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 short or rapid acting insulin since the time of diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or hospitalization,
• Use of any product containing short or rapid acting 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 standard of care” 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
• 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method