Type 1 diabetes MedDRA version: 7.0 Level: PT Classification code 10012608
Conditions
Interventions
Trade Name: Levemir
Product Name: Levemir
Product Code: NN304
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
Concentration number: 100 U/ml-
Trade Name: Lantus
Pro
Sponsors
Novo Nordisk Farma Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent obtained before any trial-related activities. • Type 1 diabetes according to clinical judgement. • Duration of type 1 diabetes = 12 months. • Current treatment: Basal-bolus insulin regimen = 3 months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal). • Age = 18 years of age. • HbA1c = 11.0% based on analysis from central laboratory. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors. • Proliferative retinopathy or maculopathy that has required acute treatment within the last six months. • Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by Investigator. • Impaired hepatic or renal functions as judged by the Investigator. • Cardiac problems as judged by the Investigator. • Uncontrolled hypertension (treated or untreated) as judged by the Investigator. • Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation. • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures (in Sweden and France barrier methods are not accepted as adequate contraceptives).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the glycaemic control of insulin detemir with that of insulin glargine as measured by HbA1c in subjects with type 1 diabetes on a basal-bolus regimen with insulin aspart as bolus insulin after 52 weeks of treatment. ;Secondary Objective: To compare the two treatments: • Proportion of subjects with HbA1c = 7.0 % after 52 weeks of treatment. • Proportion of subjects with HbA1c = 7.0 % without any episodes of major hypoglycaemia during the last month of treatment. • Glycaemic control (FPG and 10-point SMPG profiles). • Within-subject variation of SMPG. • Incidence of hypoglycaemic episodes. • The safety profile (occurrence of AEs and laboratory safety parameters, physical examination, fundoscopy and vital signs). • Change in weight, in total daily caloric intake and snacking during the trial. • Basal and bolus insulin doses after 52 weeks of treatment. • ITSQ • Time to change of basal insulin treatment regimen, from once daily to twice daily, in the insulin detemir treated group. • Proportion of insulin detemir-treated subjects on once daily basal insulin after 52 weeks of treatment. • S-ACE (susceptibility to hypos). • S-adiponectin (insulin sensitivity and weight change). ;Primary end point(s): HbA1c after 52 weeks of treatment | — |
Countries
Finland, Sweden
Outcome results
None listed