Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin (OPTIMIZATION)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
313 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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