Typ 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Levemir
Pharmaceutical Form: Solution for injection
Trade Name: Lantus
Pharmaceutical Form: Solution for injection
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > 18 years and 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 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: - Previous therapy with insulin 3 months prior to inclusion into the study - Previous therapy with glitazones 6 months prior to inclusion into the study - Change in therapy with lipid-lowering or anti-hypertensive agent 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 - Cardiac and macrovascular 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: cirrhosis or chronic active hepatitis, except fat liver - 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) o Anaemia: Hb 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, probably non compliant subjects, and those judged by the investigator to be unsuitable for the study - Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia - Known hypersensitivity to insuline detemir, insulin glargine or to any of the other components (see SPC/”Fachinformation appendix 17.2. and 17.3.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: - To describe the weight change from baseline to month 12 between groups - To evaluate 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 insulin dose between groups - To describe the fasting blood glucose between groups - To evaluate hypoglycaemia between groups - To evaluate safety between groups ;Primary end point(s): To describe changes in hepatic fat content between groups | — |
Countries
Austria, Germany
Outcome results
None listed