Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: \- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs) Secondary Objectives: * To evaluate the percentage of patients with Hb A1c \< 7.5%, * To evaluate the rate of hypoglycaemia (symptomatic, severe) * To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment * To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment * To assess the overall safety * To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)
Detailed description
6 months
Interventions
DRUGinsulin human (HR1799)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs * Males and Female \> 18 years * HbA1c \> 7.5% * Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire * It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment
Exclusion criteria
: * Type 1 diabetes * Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial) * Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult * Patient planning a pregnancy now or in the next 6 months * The patient is participating in another clinical study now or in the last 28 days prior to Visit 1 * The patient is a drug user (currently or in the past) 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 |
|---|---|
| Decrease of Hb A1c ≥ 1% | Baseline, 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hypoglycaemias (symptomatic, severe) | 6 months | — |
| Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid) | 6 months | — |
| Percentage of patients with Hb A1c < 7.5% | 6 months | — |
| Number of patients with adverse events | 6 months | — |
| Assessment of efficacy of education courses in Diabetes Schools | Baseline, 6 months | Percentage of correct answers after second test compare to the testing of the initial level |
| Change in FPG | Baseline 6 months | — |
Countries
Ukraine
Outcome results
None listed