Diabetes Mellitus Type II
Conditions
Brief summary
A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus
Interventions
DRUGInsulin Glargine
Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes Mellitus diagnosed at least 3 years ago * Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry * Treated with OHA monotherapy over at least 1 year * HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit) * BMI \< 40 kg/m2 * No history of ketonemia * Women of childbearing potential using the medically approved contraceptive method * Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol 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 |
|---|---|
| To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG. | — |
Outcome results
None listed