diabetes tipo 2 MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: Levemir
Product Name: Levemir
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concent
Sponsors
Novo Nordisk Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 6.5 and = 11% based on analysis from central laboratory 5. BMI = 27.5kg/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) in the last 6 months, except 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. Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, NSAIDs, tricyclic anti-depressants, atypical anti-psychotics) 3. Participation in a clinical study of weight control within the last 3 months prior to screening into this trial 4. Previous or planned surgical treatment of obesity 5. 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. 6. Total daily insulin dose = 2 IU/kg. 7. 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. 8. Proliferative retinopathy or maculopathy that has required acute treatment within the last six months. 9. Uncontrolled hypertension (treated or untreated) as judged by the Investigator 10. Known or suspected allergy to trial product(s) or related products. 11. Previous participation in this trial. Participation is defined as screened. 12. 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. 13. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 14. Any condition that the Investigator feels would interfere with trial participation or evaluation of results. 15. Receipt of any investigational drug within 1 month prior to this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the change in trunk fat mass, assessed by DEXA, after 26 weeks of treatment with insulin detemir or insulin NPH (both with insulin aspart in the main meals) in overweight and obese type 2 diabetic subjects.;Secondary Objective: To compare the two treatments with respect to: • Efficacy: - Additional for DEXA: Whole Body Fat Mass (g), Whole Body Lean Mass (g), Trunk Lean Mass (g), Calculated Whole Body Fat Percentage and Calculated Trunk Fat Percentage - To quantify the relationship between BMI and required daily dose of insulin detemir - CT scan: Visceral Adipose Tissue Area (cm2), Subcutaneous Adipose Tissue Area (cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio and Liver/Spleen Attenuation Ratio (L/S) - Change in: - HbA1c from baseline to 12 and 26 weeks of treatment. - Fasting plasma glucose from baseline to 12 and 26 weeks of treatment. - cytokine in the adipose tissue (adiponectin) from baseline to 26 weeks of Treatment - Waist and hip circumference from baseline to end of treatment - Change of inflammatory parameters (hsCRP and PAI-1) from baseline to 26 weeks of treatment - Change of weight from baseline to 26 weeks of treatment ;Primary end point(s): The change in trunk fat mass (g), assessed by DEXA scan at baseline and at week 26, will be the primary endpoint. | — |
Countries
Spain
Outcome results
None listed