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| ID | Type | Description | Link |
|---|---|---|---|
| LEV-002 |
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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
| University of Bern | OTHER |
| CenTrial GmbH | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin Levemir | Experimental |
| |
| insulin Lantus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin Levemir | Drug | The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe changes in hepatic fat content between groups. | week 26, week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 evaluate changes in body fat and visceral adipose tissue between groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Fritsche, Prof. Dr. | University Hospital of Tübingen | Principal Investigator |
| Hermann Toplak, Prof. Dr. | Universitäts-Frauenklinik Graz | Principal Investigator |
| Peter Diem, Prof. Dr. | Bern University Hospital | Study Chair |
| Alexandra Kautzky-Willer, Prof. Dr. | Medical University Vienna | Study Chair |
| Thomas Pieber, Univ. Prof. Dr. | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | 8036 | Austria | |||
| University Hospital Graz |
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| insulin Lantus | Drug | The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm. |
|
| 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 evaluate the daily insulin dose between groups. | 1 year |
| To describe the fasting blood glucose between groups. | 1 year |
| To evaluate hypoglycaemia between groups. | 1 year |
| To evaluate safety between groups. | 1 year |
| Graz |
| 8036 |
| Austria |
| Medical University Vienna | Vienna | 1090 | Austria |
| University Hospital of Tübingen | Tübingen | 72076 | Germany |
| University Hospital | Bern | 3010 | Switzerland |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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