| Trial ID: | L1385 |
| Source ID: | NCT01394341
|
| Associated Drug: |
Liraglutide
|
| Title: |
Liraglutide Treatment to Patients With Severe Renal Insufficiency
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|End-stage Renal Disease
|
| Interventions: |
DRUG: Liraglutide
|
| Outcome Measures: |
Primary: Plasma liraglutide concentration (pmol/L), Plasma liraglutide concentration evaluated over time during continuous intervention, 12 weeks | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Bo Feldt-Rasmussen | Collaborators: Novo Nordisk A/S|The GCP unit at Copenhagen University Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-09
|
| Completion Date: |
2013-10
|
| Results First Posted: |
|
| Last Update Posted: |
2013-10-09
|
| Locations: |
Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet, Copenhagen Ø, Copenhagen, 2100, Denmark|Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet, Copenhagen Ø, Copenhagen, 2100, Denmark|Department of Internal Medicine H, Hillerød Hospital, Hillerød, 3400, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT01394341
|
