The effect of liraglutide on the treatment of coronary artery disease and type 2 diabetes

Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes - AddHope2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005405-78-DK

Enrollment

Registered

2012-01-04

Start date

2012-02-01

Completion date

Unknown

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffering of both Type 2 diabetes mellitus and coronary artery disease MedDRA version: 14.1 Level: LLT Classification code 10011079 Term: Coronary artery disease NOS System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Victoza Product Name: Liraglutide Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stable CAD documented by either; a) previous MI (a minimum of 6 weeks after acute MI) b) previous coronary revascularization c) CAD confirmed by an abnormal coronary arteriograph (CAG) or CT-angiography showing stenosis > 50% of any major coronary arteries. Body mass index (BMI) >/= 25,0 kg/m2 Age from 18 to 85 years of age Type 2 diabetes diagnosed either as: a) HbA1c >/= 6.5% but /= 7.0 mmol/l (confirmed) c) HbA1c /= 11.1 mmol/l The data for glucose metabolism are accepted provided that they have been obtained within 20 weeks before screening of the patient. The glucose metabolic categories are defined by ADA and WHO criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Type 1 diabetes mellitus defined as C-peptide 2; Ejection Fraction x2 greater than upper normal level) Renal diseases (eGFR < 50) Any chronic medical condition to unduly increase risk for the potential enrollee as judge by study investigators Anemia (<85% of lower normal limit), leucopenia (<85% of lower normal limit), or thrombocytopenia (< 85% of lower normal limit) Pregnancy or failure to comply with contraceptional planning within two years, or breastfeeding Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators Use of immunosuppressive therapy in the preceding 12 months Chronic pancreatitis / previous acute pancreatitis Known or suspected hypersensitivity to trial product(s) or related products Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics (Exenatide), which in the Investigator’s opinion could interfere with glucose metabolism Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the Investigator’s opinion could interfere with the results of the trail Inflammatory bowel disease Previous bowel resection Clinical signs of diabetic gastroparesis The receipt of any investigational product 90 days prior to this trial Screening calcitonin = 50 ng/l Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2 Refusal to sign informed consent.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Endocrine: 1) Beta-cell function (disposition index) as measures during an intravenous glucose tolerance test (By Bergman Minimal Model) Cardiovascular: 1) Dobutamine (stress) induced changes in Left ventricular ejection fraction (LVEF) ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated at baseline (week 0), after week 12, after week 14 (following 2 weeks of wash-out) and finallty after week 26;Main Objective: Main Objective of the Trial To investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves betacell function b) improves left ventricular ejection fraction (LVEF) during stress test in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD) ;Secondary Objective: Secondary Objective of the Trial To investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves insulin sensitivity and food induced glucagon response b) improves prognostic markers of cardiovascular disease,including 24 h heart rate variability (HRV) and diurnal blood pressure in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)	—

Measure

Time frame

Primary end point(s): Endocrine: 1) Beta-cell function (disposition index) as measures during an intravenous glucose tolerance test (By Bergman Minimal Model) Cardiovascular: 1) Dobutamine (stress) induced changes in Left ventricular ejection fraction (LVEF) ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated at baseline (week 0), after week 12, after week 14 (following 2 weeks of wash-out) and finallty after week 26;Main Objective: Main Objective of the Trial To investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves betacell function b) improves left ventricular ejection fraction (LVEF) during stress test in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD) ;Secondary Objective: Secondary Objective of the Trial To investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves insulin sensitivity and food induced glucagon response b) improves prognostic markers of cardiovascular disease,including 24 h heart rate variability (HRV) and diurnal blood pressure in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)

—

Secondary

Measure	Time frame
Secondary end point(s): Endocrine/metabolic: a) Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test b) 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) c) CRP, TNFa and IL-6 in plasma and gene expression of IL6 and TNFa in sc. fat d) NEFA during FSIGT by use of NEFA minimal model Cardiovascular: a) Heart rate variability in particular SDNN, i.e. the standard deviation of all normal RR interval assessed during HOLTER monitoring) b) Maximal velocity of the myocardium in systole (s´) and in diastole (e´) during the dobutamine stress test c) Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec) d) ST-depression and ectopic activity assessed during 24h HOLTER monitoring e) Diurnal blood pressure f) Diastolic heart function (E/E*) in rest and during stress g) The liraglutide effect on LVEF during the dobutamine stress test is supposed to be most prominent in those patients with remaining ischemic components of the heart, i.e. those with significant stenosis where fully revascularization has not been obtained. ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated at baseline (week 0), after week 12, after week 14 (following 2 weeks of wash-out) and finallty after week 26	—

Measure

Time frame

Secondary end point(s): Endocrine/metabolic: a) Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test b) 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) c) CRP, TNFa and IL-6 in plasma and gene expression of IL6 and TNFa in sc. fat d) NEFA during FSIGT by use of NEFA minimal model Cardiovascular: a) Heart rate variability in particular SDNN, i.e. the standard deviation of all normal RR interval assessed during HOLTER monitoring) b) Maximal velocity of the myocardium in systole (s´) and in diastole (e´) during the dobutamine stress test c) Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec) d) ST-depression and ectopic activity assessed during 24h HOLTER monitoring e) Diurnal blood pressure f) Diastolic heart function (E/E*) in rest and during stress g) The liraglutide effect on LVEF during the dobutamine stress test is supposed to be most prominent in those patients with remaining ischemic components of the heart, i.e. those with significant stenosis where fully revascularization has not been obtained. ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated at baseline (week 0), after week 12, after week 14 (following 2 weeks of wash-out) and finallty after week 26

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Countries

Denmark

Contacts

Public ContactAhmad Sajadieh, MD, DMSc

Dept Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark

asajadieh@yahoo.com+4525330519

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 7, 2026