Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary objective: To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD) Secondary objective: Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life with basal+ OAD regimen.
Interventions
DRUGInsulin Glargine
Once daily and up-titrate accordingly
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs * 7.5 ≤ HbA1c ≤ 9.5% * FPG ≥6.7 mmol/L * History of Diabetes mellitus ≤10 years * Premix insulin daily dosage ≤ 50 IU/Day
Exclusion criteria
* Type 1 Diabetes Mellitus * Former treated on TZD * Pregnancy / Lactation * Creatine ≥1.5 mg/dl * Hepatic disease, jaundice,or ALT/AST≥ 2.5 times of normal range * Hormone therapy, * Acute status of Diabetes complications * Severe concomitant disease or complications with high risk of unexpected fatal events, like Myocardial Infarct, stroke, heart failure. * Allergic to insulin glargine or any ingredient * Participation in another clinical trial within 3 months 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 |
|---|---|
| HbA1c values | At baseline and 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events including hypoglycemia | From the beginning to the end of the study |
Countries
China
Outcome results
None listed