Comparison of Patient- Versus Physician-managed Titration of Insulin Glargine U300 in Type 2 Diabetes Mellitus patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 592

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

-Age <18 years old.
-HbA1c at screening visit:
-<7.0% or >10.0% for patients taking basal insulin.
-<7.5% or >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.

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

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