| Trial ID: | L2520 |
| Source ID: | NCT01425580
|
| Associated Drug: |
Liraglutide
|
| Title: |
Liraglutide and Heart Failure in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Congestive Heart Failure|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: liraglutide|DRUG: glimepiride|DRUG: Metformin
|
| Outcome Measures: |
Primary: Left ventricle longitudinal function and/or functional reserve during rest and/or after exercise using tissue Doppler echocardiography, 18 weeks | Secondary: 24-hour blood pressure, 18 weeks|Energy delivering from the carotid artery, 18 weeks|N-terminal pro b-type natriuretic peptide (NT-proBNP) levels in serum over time and symptoms of dyspnea or fatigue as assessed by patient and clinician using established scoring systems, 18 weeks|Gene and protein expression (Affymetrix/proteomics), 18 weeks|Plasma markers of inflammation i.e. hsCRP, IL-6, TNF-α and PAI-1, 18 weeks|Plasma markers of endothelial activation i.e. E-selectin, VCAM-1, ICAM-1 and plasma levels of nitrate/nitrite, 18 weeks|Lipids, 18 weeks|A1c, 18 week|Body weight, 18 weeks|Adverse events in terms of hypoglycaemia, 18 weeks|Quality of life (SF 36), 18 weeks|Exercise ECG, including working capacity, 18 weeks|Global LV function (echocardiography) expressed as ejection fraction (EF), 18 weeks
|
| Sponsor/Collaborators: |
Sponsor: Thomas Nystrom | Collaborators: Örebro University, Sweden
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
62
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-01
|
| Completion Date: |
2016-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-09-01
|
| Locations: |
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, 118 83, Sweden|Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB, Stockholm, 118 83, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT01425580
|
