MULTINATIONAL, MULTICENTRIC, RANDOMIZED, OPEN STUDY TO ESTABLISH THE OPTIMUM METHOD FOR INITIATING AND MAINTAINING LANTUS THERAPY (INSULIN GLARGINE) BASED ON THE COMPARISON OF TWO TREATMENT ALGORITHMS TO DETERMINE THE OPTIMUM METABOLIC CONTROL, SECURITY AND SATISFACTION IN SUBJECTS WITH DIABETES MELLITUS TYPE 2
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsNon-insulin-dependent diabetes mellitus, without complicationsE119
- Registration Number
- PER-045-02
- Lead Sponsor
- AVENTIS PHARMA S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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<br>Measure:Severe hypoglycaemia frequency<br>Timepoints:12 week<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:HbA1c<br>Measure:changes in HbA1c values<br>Timepoints:week 12 and 24<br>