Type 1 Diabetes Mellitus (T1DM)
Conditions
Interventions
Trade Name: Lantus
Product Name: Lantus
Product Code: HOE901
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Glargine
Concentration unit: IU/ml international unit(s)/millilitr
Sponsors
Karolinska University Hospital, Stockholms Läns Landsting
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Diagnosis of Diabetes Mellitus and novel to insulin therapy 2) Age 7.0-16.99 years 3) Informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Exclusion criteria: 1) Moderate to severe ketoacidosis (pH<7.2 and/or standardbicarbonate <10 mmol/l) 2) Suspected non-type 1 3) IA2, GAD65, IAA: all-antibody negative 4) Celiac disease or other chronic disease 5) Hypothyroidism, if not well controlled 6) Syndromes 7) Previous anorexia nervosa 8) Neuro-psychiatric disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if metabolic control (HbA1C) is improved in patients treated for 12 month from diagnosis with new long-acting basal insulin analogs (Lantus or Levemir) compared to pateints treated with NPH insulin (Insulatard). ;Secondary Objective: To study if - metabolic control is improved at 3 and 6 month - glucose variablility and hypoglycemic events are decreased at 3, 6 and 12 month - improved metabolic control can be partly explained by sustained/increased endogenous insulin production at 3, 6 and 12 month - improved metabolic control can be partly explained by closer to normal IGF-I, IGFBP-3 and IGFBP-1 levels at 3, 6 and 12 month - quality of life is improved in patients treated from diagnosis with new long-acting basal insulin analogs (Lantus or Levemir) compared to to pateints treated with NPH insulin (Insulatard). ;Primary end point(s): HbA1C after 1 year of treatment from diagnosis with Lantus, Levemir or NPH in adolesents with T1DM Secondary endpoints HbA1C at 3 and 6 month of treatment - Stimulated C-peptide at 3, 6 and 12 month of treatment - IGF-I, IGFBP-1 and IGFBP-3 at 3, 6 and 12 month of treatment - Quality of life at 12 month of treatment - - from diagnosis with Lantus, Levemir or NPH in adolesents with T1DM | — |
Countries
Sweden
Outcome results
None listed