Type 2 diabetes MedDRA version: 7.0 Level: PT Classification code 10012613
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
Prod
Sponsors
Novo Nordisk Farma Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent obtained before any trial-related activities. 2.Type 2 diabetes according to clinical judgement. 3.Duration of type 2 diabetes =12 months. 4.Currently on any OAD therapy or on any insulin in any regimen with or without OADs > 4 months. For subjects on OADs, with or without insulin: •The dose of the individual OAD must be either highest tolerated dose or at least half maximum recommended dose according to local labelling =4 months prior to screening •The OAD dose(s) must be unchanged for the last month prior to screening 5.Age = 18 years. 6.BMI = 40.0 kg/m2. 7.HbA1c = 7.0 and = 11.0% based on analysis from the 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: 1.Treatment with thiazolidinediones or metformin which does not adhere to the approved product information for the respective country 2.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. 3.Proliferative retinopathy or maculopathy that has required acute treatment within the last six months. 4.Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator. 5.Impaired hepatic or renal function as judged by the Investigator. 6.Cardiac problems as judged by the Investigator. 7.Uncontrolled hypertension (treated or untreated) as judged by the Investigator. 8.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation. 9.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 2 diabetes on a basal-bolus regimen with insulin aspart as bolus insulin after a 52 week treatment period.;Secondary Objective: 1.Proportion of subjects with HbA1c =7.0% after 52 weeks of treatment. 2.Proportion of subjects with HbA1c =7.0% without symptomatic hypoglycaemia confirmed by plasma glucose value <4.0mmol/l or any single plasma glucose value <3.1mmol/l in the last 3 months of treatment. 3.Glycaemic control as measured by fasting plasma glucose during the trial. 4.Within-subject variation of self measured plasma glucose before breakfast and dinner during the trial. 5.Glycaemic control as measured by 10-point SMPG profiles during the trial. 6.Incidence of hypoglycaemic episodes during the trial; nocturnal and over the entire day. 7.The safety profile as measured by occurrence of adverse events during the trial 8. The safety profile as measured by lab. safety parameters, phys. examination, fundoscopy/fundusphotography and vital signs. 9.Weight change during the trial. 10.Basal and bolus insulin doses after 52 weeks of treatment. 11.Insulin treatment satisfaction assessed by the ITSQ during the trial.;Primary end point(s): HbA1c after 52 weeks of treatment. | — |
Countries
Finland, Sweden
Outcome results
None listed