Diabetes, Obesity
Conditions
Keywords
insulin therapy, hepatic fat, type 2 diabetes, body composition, comparison of insulin detemir and insulin glargine, Changes in Hepatic Fat, Obesity
Brief summary
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.
Interventions
DRUGinsulin Levemir
The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
DRUGinsulin Lantus
The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.
Sponsors
Medical University of Vienna
University of Bern
CenTrial GmbH
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years and \< 80 years * Gender: female, male * Type 2 diabetes * BMI: 20.0 - 38.0 * Anti-GAD antibody negative * Fasting blood glucose \> 126 mg/dl * HbA1c 7.0 - 11.0% * Need for insulin therapy
Exclusion criteria
* Previous therapy with insulin within the last 3 months prior to inclusion into the study * Previous therapy with glitazones within the last 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-hypertensive therapy is allowed) * Concomitant participation in other clinical trials * Type 1 diabetes * Cardiac and macrovascular disease * Malignancy including leukaemia and lymphoma within the last 5 years * Liver disease: cirrhosis or chronic active hepatitis, except fat liver * Significant renal dysfunction * other Endocrine disease * significant laboratory abnormalities * History of active substance abuse (including an average alcohol consume of \> 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 insulin detemir, insulin glargine or to any of the other components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe changes in hepatic fat content between groups. | week 26, week 52 |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate changes in body fat and visceral adipose tissue between groups. | week 26, week 52 |
| To describe changes in waist and hip circumferences between groups. | weel 26, week 52 |
| To describe changes in eating behavior and food selection between groups. | week 26, week 52 |
| To describe changes in well being and disease perception between groups. | week 26, week 52 |
| To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine. | week 26, week 52 |
| To describe the fasting blood glucose between groups. | 1 year |
| To evaluate hypoglycaemia between groups. | 1 year |
| To evaluate safety between groups. | 1 year |
| To evaluate the daily insulin dose between groups. | 1 year |
Countries
Austria, Germany, Switzerland
Outcome results
None listed