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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002285-76 | EudraCT Number |
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| Name | Class |
|---|---|
| Steno Diabetes Center Copenhagen | OTHER |
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A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes patients in suboptimal glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months |
|
| Placebo | Placebo Comparator | Placebo; daily subcutaneous injection; 1.8 mg; 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline to end of study (time 6 months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Change in weight from baseline to end of study (time 6 months) | 6 months |
| Change in insulin pump settings | Change in insulin pump settings from baseline to 3 weeks, 3 months and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Nørgaard, MD, DMSc | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center | Gentofte Municipality | 2820 | Denmark | |||
| Hvidovre University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31696598 | Result | Dejgaard TF, Schmidt S, Frandsen CS, Vistisen D, Madsbad S, Andersen HU, Norgaard K. Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial. Diabetes Obes Metab. 2020 Apr;22(4):492-500. doi: 10.1111/dom.13911. Epub 2019 Dec 19. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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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| Drug |
|
| 6 months |
| Change in glucose variability as measured by continuous glucose monitoring | Change in glucose variability from baseline to 3 weeks, 3 months and 6 months | 6 months |
| Change in body composition as measured by DXA-scan | Change in body composition from baseline to 6 months | 6 months |
| Change in blood pressure | Change in blood pressure from baseline to 6 months | 6 months |
| Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides) | Change in lipid profile from baseline to 6 months | 6 months |
| Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l) | Frequency of hypoglycemia during the 6-month study period | 6 months |
| Change in kidney function as measured by urine albumine/creatinine ratio | Change in kidney function from baseline to 6 months | 6 months |
| Number of daily blood glucose measurements | Number of daily blood glucose measurements during the 6-month study period | 6 months |
| Change in diet as measured by retrospective food recording | Change in dietary behavior from baseline to 3 and 6 months | 6 months |
| Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire | Change in treatment satisfaction from baseline to 3 and 6 months | 6 months |
| Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale | Change in anxiety and depression from baseline to 6 months | 6 months |
| Hvidovre |
| 2650 |
| Denmark |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |