E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | Diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |