Diabetes Mellitus, Type 1
Conditions
Brief summary
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.
Interventions
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men and women (\>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40) * An HbA1c range of \>6.5 - \<11% * And on multiple injection regimen (more than 1 year of continuous insulin treatment) * Body mass index \<35.
Exclusion criteria
* Active proliferative diabetic retinopathy * Diabetes other than type I diabetes mellitus * Pancreatectomised subjects * Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine * Hypersensitivity to insulin * Major systemic diseases * Impaired hepatic or renal function 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 |
|---|---|
| Change of HbA1c. | from baseline to endpoint. |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c. | from baseline (week 1) to weeks 12 and 26 |
| Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins. | from baseline to endpoint. |
Countries
Russia
Outcome results
None listed