None listed
Conditions
Interventions
Subjects not previously submitted to insulin treatment will start with a fixed dose of insulin glargine that will be adjusted weekly, depending on the GA values, in 2, 4, 6 or 8 units of insulin.
Group name:GROUP II Type of group
Subjects not previously treated with insulin will start with a dose equal to the highest value of the last 7 consecutive values of GA (mmol / I), which will be subsequently adjusted by 2 units each time the average GA is above the value diana for 3 consecutive days.
Sponsors
AVENTIS PHARMA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with diabetes mellitus type 11 in antidiabetic treatment (oral and / or insulin) for> 6 months that require a long-acting basal insulin for the control of hyperglycemia. 2. Glycosylated hemoglobin> 7.0% and <12%; 3. Age equal to or greater than 18 years; 4. body mass index (BMI) <40 kg / m2; 5. Willingness to accept treatment and ability to inject insulin glargine; 6. Ability and willingness to carry out self-determinations of blood glucose (ADG) using a glucometer.
Exclusion criteria
Exclusion criteria: 1. Impaired renal function, evidenced (among others) by serum creatinine> 177 pmol / 1 (> 2.0 mg / dl) at visit 1 or currently on renal dialysis. 2. Acute metabolic acidosis (> 1 episode in the last year) or chronic, including diabetic ketoacidosis. 3. Clinical evidence of active liver disease, or serum ALT / AST> 2.5 times the upper limit of normal. 4. History of unnoticed hypoglycaemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Episode with symptoms of hypoglycemia in which the subject has required the assistance of another person, which is associated with a blood glucose value below 2.8 mmol / L Measure:Severe hypoglycaemia frequency Timepoints:12 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c Measure:changes in HbA1c values Timepoints:week 12 and 24 | — |
Countries
Peru, United States
Outcome results
None listed