LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous
Phase 4
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00322075
- Lead Sponsor
- Sanofi
- Brief Summary
Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year
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Exclusion Criteria
- Diabetic ketoacidosis
- Any other severe disease
- Pregnancy or fertile female without contraception
- Alcohol/drug abuse, selected prohibited concomitant medication
- Nightshift work
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 3 days continual glycaemic profile fluctuation occurrence of adverse events HbA1c FBG BMI total daily dose of insulin and ratio of doses of basal/prandial insulines patients´satisfaction
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇨🇿Prague, Czech Republic