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 | 10045242 |
E.1.2 | Term | Type II 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 |
The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today’s standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.
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E.2.2 | Secondary objectives of the trial |
- To describe changes in body weight between groups - To describe changes in HbA1C between groups - To evaluate changes in body fat and visceral adipose tissue between groups - To describe changes in waist and hip circumferences between groups - To describe changes in eating behaviour and food selection between groups - To describe changes in well being and disease perception between groups - To evaluate the daily insuline dose between groups - To describe the fasting blood glucose between groups - To evaluate hypoglycaemia between groups - To evaluate safety between groups
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age > 18 years and < 80 years - Gender: female, male - Type 2 diabetes - BMI: 20.0 – 38.0 (higher, if MRI is possible) - Anti-GAD antibody negative - Fasting blood glucose > 126 mg/dl - HbA1c 7.0 – 11.0% - Previous therapy with metformin or sulfonylurea or glinide or a combination of metformin with sulfonyurea or metformin with glinide. - Minimal dose per day: 3.5mg Glibenclamid, 3mg Glimepirid, at least 1500mg Metformin, 3mg Repaglinid, 300mg Nateglinid, 60mg Gliclazid MR - Stable oral therapy for at least 3 months - Female patients must have a negative urine pregnancy test prior to study entry and must be either at least two years postmenopausal or using one of the following means of birth control: surgical sterility, double barrier methods, intraunterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods. It is assumed that contraception for male patients is not considered as medically important. - Signed written informed consent to participate in the study
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E.4 | Principal exclusion criteria |
- Previous therapy with insulin 3 months prior to inclusion into the study - Previous therapy with glitazones 6 months prior to inclusion into the study - Changesin therapy with lipid-lowering or anti-hypertensive agents within one month prior to inclusion into the study (a stable lipid-lowering or anti-hyperensive therapy is allowed ) - Concomitant participation in other clinical trials - Type 1 diabetes - Cardiovascular disease : o Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs. o Percutaneous coronary intervention within the past 6 months. o Any of the following within the past 6 months: myocardial infarction (MI) (If the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the subject can enter the study at the discretion of the investigator); coronary artery bypass surgery; unstable angina; or stroke. o Congestive heart failure NYHA class III or IV - Malignancy including leukemia and lymphoma within the last 5 years - Liver disease such as cirrhosis or chronic active hepatitis - Significant renal dysfunction (see also exclusion criteria laboratory abnormalities) - Endocrine disease: o Acromegaly or treatment with growth hormone or similar drugs. o Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks o Thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the TSH is within normal limits - Any of the following significant laboratory abnormalities: o Serum creatinine levels ≥ 2.5 mg/dl (220 mol/l) o Fasting triglycerides 700 mg/dl (>7.9 mmol/l) - History of active substance abuse (including alcohol > 40g/day and drugs) within the past 2 years - Female patients: Pregnancy or childbearing potential without adequate contraception (for male patients contraception is not considered as medically important) - Present therapy with systemic steroids - Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s - Use of anti-obesity drugs 3 months prior or during the trial - Potentially unreliable subjects, and those judged by the investigator to be unsuitable for the study - Persons who are not familiar with the insulin injection system - Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia - Missing signed written informed consent to participate in the study - Known hypersensitivity to insuline detemir, insulin glargine or to any of the other components (see SPC/”Fachinformation appendix 17.2. and 17.3.)
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E.5 End points |
E.5.1 | Primary end point(s) |
To describe changes in hepatic fat content between groups. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |