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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021922-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| University of Copenhagen | OTHER |
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Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin. The novel and original aspect of this investigator-initiated study is the focus on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients with severely reduced kidney function. At present there is virtually no knowledge of the physiology and clinical implications of the role of incretin hormones and incretin-based therapy in this group of diabetic patients.The aim of the study is to establish an evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and reducing risk factors of cardiovascular disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2D, Dialysis, Liraglutide | Active Comparator | Daily liraglutide treatment Chronic dialysis treatment |
|
| T2D, Dialysis, Placebo | Placebo Comparator | Daily placebo Chronic dialysis treatment |
|
| T2D, Normal kidney function, Liraglutide | Active Comparator | Daily Liraglutide treatment Normal kidney function |
|
| T2D, Normal kidney function, Placebo | Placebo Comparator | Daily placebo treatment Normal kidney function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Daily sc. injection, individual dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma liraglutide concentration (pmol/L) | Plasma liraglutide concentration evaluated over time during continuous intervention | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycaemia; minor or major | Number of hypoglycaemic episodes during intervention. Minor (blood glucose <3.1 mmol/L, no need for assistance). Major (blood glucose <3.1 mmol/L, assistance from third person required) | 12 weeks |
| Glycaemic control |
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Inclusion criteria - patients with T2D in dialysis
Inclusion criteria - patients with T2D and normal kidney function
Exclusion Criteria - both groups
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| Name | Affiliation | Role |
|---|---|---|
| Bo Feldt-Rasmussen, Prof, DMSc | Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet | Study Director |
| Thomas Idorn, MD | Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet | Copenhagen Ø | Copenhagen | 2100 | Denmark | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39963952 | Derived | Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2. | |
| 26283739 | Derived | Idorn T, Knop FK, Jorgensen MB, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease: An Investigator-Initiated, Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Trial. Diabetes Care. 2016 Feb;39(2):206-13. doi: 10.2337/dc15-1025. Epub 2015 Aug 17. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007676 | Kidney Failure, Chronic |
| D014511 | Uremia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Glycaemic control evaluated from 3 daily measurements of blood glucose, from 4 periods of 24-hour tissue glucose measurements (5 days each) and from HbA1c during the intervention period.
| 12 weeka |
| Pancreatic beta-cell function | Pancreatic beta-cell function evaluated from insulin- and C-peptide-secretion during a standard meal test 3 times during the intervention period. | 12 weeks |
| Cardiovascular risk factors (lipids and blood pressure) | Blood pressure will be evaluated at each visit and lipid profile (HDL, LDL, total cholesterol and triglyceride) 3 times during the intervention period. | 12 weeks |
| Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet |
| Copenhagen Ø |
| Copenhagen |
| 2100 |
| Denmark |
| Department of Internal Medicine H, Hillerød Hospital | Hillerød | 3400 | Denmark |
| 23624993 | Derived | Idorn T, Knop FK, Jorgensen M, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and efficacy of liraglutide in patients with type 2 diabetes and end-stage renal disease: protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded, parallel intervention study. BMJ Open. 2013 Apr 26;3(4):e002764. doi: 10.1136/bmjopen-2013-002764. Print 2013. |
| D004700 | Endocrine System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |