Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement. Secondary Objectives: * Evolution of fasting plasma glucose * Evolution of insulin dose and body weight * Hypoglycemia incidence * Safety * Patients satisfaction when they change their insulin for HOE901-U300
Detailed description
The total study duration per patient is approximately 28 weeks.
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist * HbA1c \> 7.5%
Exclusion criteria
* Patients with high dose of insulin (\>1.2 U/kg) * Use of prandial insulin * Change of dose of antidiabetic drugs within the last 8 weeks * Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in HbA1c | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with HbA1c <7%, <7.5%, and <8% | At Week 24 |
| Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%) | Baseline to Week 12 and Week 24 |
| Mean change from baseline in fasting plasma glucose | Baseline to Week 12 and Week 24 |
| Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL) | At Weeks 12 and 24 |
| Change in Diabetes Treatment Satisfaction Questionnaire score | Week 24 |
| Number of hypoglycemic events | From inclusion up to Week 24 |
| Number of adverse events | From inclusion up to Week 24 |
| Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Baseline to Week 24 |
Countries
France
Outcome results
None listed