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Clinical Trial Details

Trial ID: L2909
Source ID: NCT01595789
Associated Drug: Liraglutide
Title: The Effect of Liraglutide on the Treatment of Coronary Artery Disease and Type 2 Diabetes
Acronym: AddHope2
Status: COMPLETED
Study Results: NO
Results:
Conditions: Coronary Artery Disease|Diabetes Mellitus, Type 2
Interventions: DRUG: Liraglutide|DRUG: Placebo
Outcome Measures: Primary: Beta-cell function, Beta-cell function (disposition index) as measured during an intravenous glucose tolerance test (By Bergman Minimal Model), after 12 weeks of intervention|LVEF, Changes in LVEF assessed by dobutamine stress echocardiography, after 12 weeks of intervention | Secondary: Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test, Baseline (week 0), week 12, week 14, week 26|Insulin sensitivity (Si), acute insulin and C-peptide response to intravenous glucose (AIRg, ACRg), glucose clearance (Kg), glucose effectiveness (Sg) and hepatic extraction of insulin (HEXi), Insulin sensitivity (Si), acute insulin and C-peptide response to intravenous glucose (AIRg, ACRg), glucose clearance (Kg), glucose effectiveness (Sg) and hepatic extraction of insulin (HEXi) derived from a standard frequent sampling intravenous glucose tolerance test (FSIGT, Minimal model), Baseline (week 0), week 12, week 14, week 26|CRP, TNF-alfa and IL-6 in plasma and gene expression of IL6 and TNF-alfa in subcutaneous fat, Baseline (week 0), week 12, week 14, week 26|Non esterified fatty acids (NEFA), NEFA during FSIGT by use of NEFA minimal model, Baseline (week 0), week 12, week 14, week 26|Heart rate variability (HRV), HRV i.e. SDNN (standard deviation of all normal RR interval) assessed during HOLTER monitoring, Baseline (week 0), week 12, week 14, week 26|Maximal velocity of the myocardium in systole (s´) and in diastole (e´), Maximal velocity of the myocardium in systole (s´) and in diastole (e´) during the dobutamine stress test, Baseline (week 0), week 12, week 14, week 26|Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec), Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec), Baseline (week 0), week 12, week 14, week 26|ST-depression and ectopic activity, ST-depression and ectopic activity assessed during 24h HOLTER monitoring, Baseline (week 0), week 12, week 14, week 26|Diurnal blood pressure, Baseline (week 0), week 12, week 14, week 26|Diastolic heart function (E/E*), Diastolic heart function (E/E\*) in rest and during stress, Baseline (week 0), week 12, week 14, week 26
Sponsor/Collaborators: Sponsor: Haugaard, Steen Bendix, M.D., DMSc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 41
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-05
Completion Date: 2015-07
Results First Posted:
Last Update Posted: 2017-03-07
Locations: Copenhagen University Hospital, Bispebjerg, Copenhagen, Bispebjerg, 2400, Denmark
URL: https://clinicaltrials.gov/show/NCT01595789