Copenhagen University Hospital, Bispebjerg
Copenhagen, Bispebjerg, 2400, Denmark
NCT Number: NCT01595789
The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1 (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly diagnosed type 2 diabetes (T2D).
It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients with T2D will improve beta-cell function, left ventricular ejection fraction (LVEF), heart rate variability and lower 24h blood pressure among other selected endpoints.
The present study on CAD patients with newly diagnosed T2D will address these selected endpoints during an investigator initiated, randomized, double blind, crossover, placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Copenhagen, Bispebjerg, 2400, Denmark
The total study period for each patient will be 26 weeks (12 plus 12 weeks of intervention with a 2 week wash-out period).
The endpoints will be evaluated at baseline (week 0), at week 12, at week 14 (following 2 weeks of wash-out) and finally at week 26.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The data for glucose metabolism are accepted provided that they have been obtained within 24 months prior to inclusion of the patient. The glucose metabolic categories are defined by ADA and WHO criteria.
Exclusion criteria
Liraglutide injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with placebo.
Other names: Brand name: Victoza, Active substance: liraglutide, EMA Product number: EMEA/H/C/001026, ATC Code: A10BX07
Volume-matched placebo injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg volume-matched placebo. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with liraglutide.
Time frame: after 12 weeks of intervention
Beta-cell function (disposition index) as measured during an intravenous glucose tolerance test (By Bergman Minimal Model)
Time frame: after 12 weeks of intervention
Changes in LVEF assessed by dobutamine stress echocardiography
Time frame: Baseline (week 0), week 12, week 14, week 26
Time frame: 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) derived from a standard frequent sampling intravenous glucose tolerance test (FSIGT, Minimal model)
Time frame: Baseline (week 0), week 12, week 14, week 26
Time frame: Baseline (week 0), week 12, week 14, week 26
NEFA during FSIGT by use of NEFA minimal model
Time frame: Baseline (week 0), week 12, week 14, week 26
HRV i.e. SDNN (standard deviation of all normal RR interval) assessed during HOLTER monitoring
Time frame: Baseline (week 0), week 12, week 14, week 26
Maximal velocity of the myocardium in systole (s´) and in diastole (e´) during the dobutamine stress test
Time frame: 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)
Time frame: Baseline (week 0), week 12, week 14, week 26
ST-depression and ectopic activity assessed during 24h HOLTER monitoring
Time frame: Baseline (week 0), week 12, week 14, week 26
Time frame: Baseline (week 0), week 12, week 14, week 26
Diastolic heart function (E/E*) in rest and during stress
Haugaard, Steen Bendix, M.D., DMSc
Indiv
Adding Liraglutide to the Backbone Therapy of Biguanide in Patients With Coronary Artery Disease and Newly Diagnosed Type-2 Diabetes
Acronym: AddHope2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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