Diabetes Mellitus
Conditions
Brief summary
Primary: * To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus. * To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro. Secondary: * To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus
Interventions
DRUGInsulin Glulisine
3 times a day before each meal
DRUGLispro
3 times a day before each meal
DRUGInsulin Glargine
once daily
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetic patients * Measure HbA1c 6.5% to 11.0% at visit 1 * More than 3 months of continuous insulin treatment immediately prior to study entry
Exclusion criteria
* Pregnant women 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 |
|---|---|
| Hypoglycemic episodes | From the beginning to end of the study |
| Change in HbA1c | From baseline to endpoint |
| Adverse events | From the beginning to the end of study |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c | From baseline to weeks 12 |
| blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus. | from baseline to week 12 |
Countries
China
Outcome results
None listed