Type 2 diabetes MedDRA version: 7.0 Level: PT Classification code 10049746
Conditions
Sponsors
Novo Nordisk Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) 2. Female or male, age =18 3. Subjects with type 2 diabetes who have been treated with 2 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion 4. HbA1c = 7.5 and = 11% based on analysis from central laboratory 5. BMI = 25 kg/m2 and = 40 kg/m2 6. Able and willing to perform self-monitoring of blood glucose. 7. Willing to accept multidose insulin therapy 8. Able to self-inject all required doses of insulin 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 any OAD (Oral Antidiabetic Drugs), excepting metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period). 2. Any disease or condition (such as renal, hepatic or cardiac) that, according to the judgement of the Investigator, makes the subject unsuitable for participation in the trial. 3. Total daily insulin dose = 2 IU/kg. 4. 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. 5. Proliferative retinopathy or maculopathy that has required acute treatment within the last six months. 6. Uncontrolled hypertension (treated or untreated) as judged by the Investigator 7. Known or suspected allergy to trial product(s) or related products. 8. Previous participation in this trial. Participation is defined as screened. 9. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods. 10. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 11. Any condition that the Investigator feels would interfere with trial participation or evaluation of results. 12. Receipt of any investigational drug within 1 month prior to this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the weight change during 26 weeks of treatment with insulin detemir versus NPH insulin in obese or overweight type 2 diabetic subjects.;Secondary Objective: Efficacy: -HbA1c at the start and after 12 & 26 weeks of treatment. -Fasting plasma glucose at the start and after 12 & 26 weeks of treatment. -7-point glucose profiles during the 26 weeks of treatment -Intra-variability of detemir and NPH insulin during 26 weeks of treatment. -Proportion of subjects reaching glycaemic control at the end of the trial -Proportion of subjects reaching pre and postprandial targets according t-titration guidelines at the end of the trial. -Relationship between BMI and required daily dose of insulin detemir Safety: -Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH -Lipid profile at the start and after 26 weeks of treatment -Incidence of Adverse events during the trial -Safety profile as measured by laboratory safety parameters and physical examination/vital signs before and at the end of treatment -Insulin resistance measured by the HOMA-IR at the start and at the end of the trial;Primary end point(s): Primary endpoint: • Weight change after 26 weeks of treatment. Secondary endpoints: Efficacy • HbA1c at the start and after 12 and 26 weeks of treatment. • Fasting plasma glucose at the start and after 12 and 26 weeks of treatment. • 7-point glucose profiles during the 26 weeks of treatment • Intra-variability of detemir and NPH insulin during 26 weeks of treatment. • Proportion of subjects reaching glycaemic control (HbA1c = 7.0%) at the end of the trial • Proportion of subjects reaching pre and postprandial targets according to titration guidelines at the end of the trial. • Relationship between BMI and required daily dose of insulin detemir Safety • Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH • Lipid profile at the start and after 26 weeks of treatment • Incidence of | — |
Countries
Spain
Outcome results
None listed