Type 2 diabetes mellitus MedDRA version: 19.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
sanofi-aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
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, Alpha glucosidae inhibitors), and with or without glucagon-like peptide-1 (GLP-1) receptor Agonist, and eligible to basal Insulin Treatment, per investigator's judgement. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of Toujeo versus “standard of care” basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change.;Secondary Objective: • To demonstrate superiority of Toujeo versus “standard of care” basal insulin if non-inferiority is met, measured as 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 the incidence of documented symptomatic or severe hypoglycemic events (as defined by the American Diabetes Association Workgroup on Hypoglycemia, • 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 hypoglycemia control subscale (HCS), • Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.;Primary end point(s): Change in HbA1c (expressed in percent);Timepoint(s) of evaluation of this end point: Baseline to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy) 2- Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not 3- Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%) 4- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (blood glucose [BG] = 70 mg/dl [3.9 mmol/L]) symptomatic or severe hypoglycemia 5- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (BG <54 mg/dl, [3.0 mmol/L]) symptomatic or severe hypoglycemia 6- Change in HbA1c (expressed in percent) 7- Percentage of patients whose HbA1c decreased at least 1% 8- Percentage of patients whose HbA1c decreased at least 1% 9- Percentage of patients requiring intensification and time to intensification 10- Change in fasting plasma glucose;Timepoint(s) of evaluation of this end point: 1, 2, 3, 4, 5 : at Month 6 and Month 12 6: Baseline to Month 12 7: at Month 6 and Month 12 8: at Month 6 and maintained at Month 12 9: at Month 6 and Month 12 10: Baseline to Month 6 and Month 12 | — |
Countries
Brazil, France, Germany, Greece, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed