Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
Detailed description
The study duration for each patient is 24 weeks +/- 1 week broken down as follows: * Run-in phase: 8 weeks * Follow - up Period: 16 weeks The maximal possible time window during the study is +/- one week throughout the study.
Interventions
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Run-in period: 1. Type 2 diabetes 2. HbA1c≥ 8.5% (in a test of the last month) 3. Age above 21 years 4. Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months 5. Signed informed consent form 6. Patients who according to their physician are eligible to the study Randomization: 1. HbA1c \> 7.5% 2. FPG \< 130 mg/dl
Exclusion criteria
1. Type 1 diabetes 2. Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months. 3. Pregnant or breastfeeding women. 4. Patients with allergy to insulin. 5. Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy. 6. Patients with mobility difficulties and/or difficulties communicating with the investigator 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 |
|---|---|
| Changes in Hemoglobin A1c (HbA1c) level | Baseline, week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of hypoglycemia | Week 24 |
| Changes in insulin glargine dose | Baseline, week 24 |
| Changes in insulin glulisine dose | Baseline, week 24 |
Countries
Israel
Outcome results
None listed