Diabetes Mellitus
Conditions
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.
Interventions
DRUGinsulin glargine
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Exclusion criteria
* Diabetic ketoacidosis * Any other severe disease * Pregnancy or fertile female without contraception * Alcohol/drug abuse, selected prohibited concomitant medication * Nightshift work
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czechia
Outcome results
None listed