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| Name | Class |
|---|---|
| University of Debrecen | OTHER |
| Szeged University | OTHER |
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This study examines prospectively the safety and efficacy of switching from multiple daily insulin injections (MDI) to once daily IDegLira (insulin degludec and liraglutide fix ratio combination), a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).
Type 2 diabetic patients suffering from severe hyperglycemia are often apply multiple daily insulin injections (MDI). If glucose toxicity resolves, the regimen may potentially be simplified, but there are no specific guidelines regarding this and a lot of patients are left on MDI.
The Investigators aimed to examine prospectively the safety and efficacy of switching from MDI to once daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).
The investigators hypothesize that in everyday clinical practice switching from low dose MDI to IDegLira in patients of different ages with well-controlled (or overcontrolled) type 2 diabetes is safe, may induce weight loss and result in similar or better glycemic control.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| de-escalation of complex insulin regimens | Other | complex insulin regimens are switched to fix ratio combinations consisting of of a basal insulin and a GLP-1 (glucagon-like peptide-1) receptor agonist |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reaching HbA1c<7% and HbA1c<6.5% | HbA1c is measuerd by laboratory blood test | it is checked at baseline and at 3, 6, 9 and 12 months |
| change in body weight from baseline to 3, 6, 9 and 12 months | body weight is measured at the diabetes ambulance | it is checked at baseline and at 3, 6, 9 and 12 months |
| change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months | hypoglycemia risk is assessed by analysing the patients' diary | it is checked at baseline and at 3, 6, 9 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Well-controlled or overtreated adult type 2 diabetic patients using relatively low dose MDI.
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| Name | Affiliation | Role |
|---|---|---|
| Zoltán J Taybani, MD | Bekes County Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zoltán Taybani | Békéscsaba | Bekes County | 5600 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31347100 | Result | Taybani Z, Botyik B, Katko M, Gyimesi A, Varkonyi T. Simplifying Complex Insulin Regimens While Preserving Good Glycemic Control in Type 2 Diabetes. Diabetes Ther. 2019 Oct;10(5):1869-1878. doi: 10.1007/s13300-019-0673-8. Epub 2019 Jul 25. |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| D007003 | Hypoglycemia |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |