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 recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with T2DM as defined by World Health Organization (WHO) diagnosed for at least 1 year at the time of the screening visit, treated with =1 non-insulin antihyperglycemic drug(s) with or without a basal insulin, for at least 6 months. -Signed informed consent 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 444 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 148
Exclusion criteria
Exclusion criteria: -Age 10.0% for patients taking basal insulin. -11.0% for insulin-naive patients. -Patient not willing to self-manage titration algorithm (including self-injection, SMPG). -Type 1 diabetes mellitus. -Insulin-pretreated patients not on a stable basal insulin regimen in the last 12 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection); the insulin dose should be stable (±20 %) for at least 8 weeks prior to screening visit. -Change in dose of existing, or initiation of new, non-insulin antidiabetic drugs in the last 12 weeks prior to screening visit. -Treatment with an insulin other than basal insulin: mixed insulin (premixes), rapid insulin, fast acting insulin analogues in the last 6 months before screening (use =10 days in relation to hospitalization or an acute illness is accepted). -Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening. -History of hypoglycemia unawareness. -Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any condition (including known substance or alcohol abuse, or psychiatric disorder) that in the opinion of the Investigator or any sub-Investigator would make implementation of the protocol or interpretation of the study results difficult or would preclude the safe participation of the subject in this protocol. -Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit. -Patients included (or planned to be included during study duration) in Toujeo Customized Patient Solution (CPS) program or any other patient support program (PSP). -Pregnant or breast-feeding women. -Women of childbearing potential not protected by highly effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. -Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To demonstrate non-inferiority in terms of glycemic control, measured as change in glycated hemoglobin (HbA1c), of a patient- versus a physician-managed titration algorithm, for the treatment with HOE901-U300 (Insulin Glargine U300), in patients with inadequately controlled Type 2 Diabetes Mellitus (T2DM).;Secondary Objective: -To evaluate the efficacy, safety, and quality of life of the two titration approaches in terms of: -Percentage of patients reaching fasting self-monitored plasma glucose (SMPG) target. -Hypoglycemic events -Change in HbA1c from baseline across subgroups of baseline HbA1c category (< 8%, = 8 to <9%, =9 %). -Safety and tolerability. -Change in Patient-Reported Outcome (PRO) instruments (Diabetes Distress Scale and Diabetes Empowerment Scale).;Primary end point(s): Mean change in HbA1c compared between the two titration modality arms (Patient- and Physician-managed titration);Timepoint(s) of evaluation of this end point: Baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Percentage of patients achieving targeted fasting SMPG (80-130 mg/dL[4.4 -7.2 mmol/L]) without experiencing severe and/or confirmed hypoglycemia3) at each occasion on the Diabetes Distress Scale (DDS) 16- Mean change on the Diabetes Empowerment Scale (DES);Timepoint(s) of evaluation of this end point: Baseline to Week 12 and Week 24 1, 4, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Baseline to Week 24 2, 3, 5 Baseline to Week 12 6 | — |
Countries
Croatia, Czech Republic, Denmark, Greece, Poland, Slovakia, Slovenia, Spain, Switzerland, United Kingdom
Contacts
Public Contactwww.sanofi.cz
sanofi-aventis, s.r.o.
Outcome results
None listed