Type 1 and 2 diabetes mellitus
Conditions
Interventions
Trade Name: Lantus
Product Name: Lantus
Product Code: HOE901
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glargine
Current Sponsor code: HOE901
Concentration unit: IU inter
Sponsors
Aventis Pharma s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 1 or 2 diabetes mellitus with NPH intensified insulin therapy and at laest 2 hypoglycemic events with BG below 3.3 mmol/l in the last 1 year Men or women aged 18 to 70 years old, inclusive HbA1c = 6 % (IFCC) before visit 1 Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindication of insulin glargine according to the SPC Pregnant women or women planning to become pregnant during the study Patients who are treated by systemic corticosateroids Alcohol abuse or current addiction to other substances of abuse Patients who take part in another clinical study Night shift workers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: glycemic fluctuations - 72 hours blood glucose monitoring with subcutaneous continuous glucose monitoring system (SCGM) at NPH treatment - basaline of the study and after 3 months of glargine period;Secondary Objective: Safety evaluation Changes of insulin daily doses Changes in FBG and HbA1c from basaline to endpoint BMI Quality of life/treatment satisfaction;Primary end point(s): Glycemic fluctuations | — |
Countries
Czech Republic
Outcome results
None listed