AddHope2

CompletedPhase 4

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

Lead sponsor

Haugaard, Steen Bendix, M.D., DMSc

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•Beta-cell function•LVEF

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01595789

Org study IDBBHAH-2011430

Secondary ID2011-005405-78

Timeline

Milestones

Study first posted2012-05-10estimated

Last update posted2017-03-07actual

Study start2012-05 (month precision)

Primary completion2014-10actual (month precision)

Study completion2015-07actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Stable CAD documented by one of the following:

–Previous MI (a minimum of 6 weeks after an acute MI)

–Previous coronary revascularization

–CAD confirmed by an abnormal coronary angiography (CAG) or CT-angiography showing stenosis > 50% of any major coronary arteries.

2. Body mass index (BMI) >/= 25,0 kg/m2

3. Age >/= 18 years and </= 85 years

4. Type 2 diabetes diagnosed by one of the following criteria:

–HbA1c >/= 6.5%

–HbA1c < 6.5 % and fasting plasma glucose >/= 7.0 mmol/l (confirmed)

–HbA1c < 6.5 % and a 2 h plasma glucose value during OGTT >/= 11.1 mmol/l

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

•Type 1 diabetes mellitus defined as C-peptide < 450 pM

•Previously diagnosed diabetes mellitus for more than 24 months prior to the screening procedure for this trial, except from gestational diabetes

•Use of more than 2 types of oral antidiabetic medication and/or use of parenteral antidiabetic medication in the period of 3 months prior to the screening visit. It is accepted that the patient continues his usual antidiabetic medication after the screening visit but antidiabetic medication must be discontinued 2 weeks prior to the baseline visit.

•Significant heart disease (NYHA > 2; Ejection Fraction < 40% and unstable angina pectoris) and known severe valve disease

•Documented atrial fibrillation or atrial flutter within 6 weeks previous to the screening. Paroxysmal atrial fibrillation is accepted if sinus rhythm is achieved at the screening.

•Uncontrolled arterial hypertension (> 180/100 mmHg) at the time of screening

•Liver (transaminases greater than x 2 the upper normal level) or renal diseases (eGFR < 60 ml/min)

•Amylase greater than x 3 the upper reference value

•Any chronic medical condition to unduly increase risk for the potential enrollee as judged by study investigators

•Dysregulated myxedema or hyperthyroid condition defined by a value of TSH < 0,1 and > 10,0 milli U/L

•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 contraception 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 judged by the investigators

•Use of immunosuppressive therapy in the preceding 12 months

•Chronic pancreatitis or 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 (e.g. 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

•Plasma calcium-ion >/= 1,45 mmol/L

•Plasma 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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Other (unclassified)

Glycemic / diabetes

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

componentstotal exercise duration, time to limiting angina, time to 1mm st segment depression

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Beta-cell function

Time frame:after 12 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test

Time frame:Baseline (week 0), week 12, week 14, week 26

descriptive

Secondary/protocol endpoint

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)

Time frame:Baseline (week 0), week 12, week 14, week 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint/low confidence

CRP, TNF-alfa and IL-6 in plasma and gene expression of IL6 and TNF-alfa in subcutaneous fat

Time frame:Baseline (week 0), week 12, week 14, week 26

hs-CRP, change

change from baseline, improvement

componentshs-CRP, change

LOINC 30522-7

Secondary/protocol endpoint

Non esterified fatty acids (NEFA)

Time frame:Baseline (week 0), week 12, week 14, week 26

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Heart rate variability (HRV)

Time frame:Baseline (week 0), week 12, week 14, week 26

change from baseline, improvement

Secondary/protocol endpoint

Diurnal blood pressure

Time frame:Baseline (week 0), week 12, week 14, week 26

change from baseline, improvement

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

LVEF

Time frame:after 12 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Maximal velocity of the myocardium in systole (s´) and in diastole (e´)

Time frame:Baseline (week 0), week 12, week 14, week 26

descriptive

Secondary/protocol endpoint/low confidence

ST-depression and ectopic activity

Time frame:Baseline (week 0), week 12, week 14, week 26

descriptive

Secondary/protocol endpoint/low confidence

Diastolic heart function (E/E*)

Time frame:Baseline (week 0), week 12, week 14, week 26

descriptive

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effects of liraglutide on diastolic function parameters in patients with type 2 diabetes and coronary artery disease: a randomized crossover study.
Cardiovascular diabetology2021 Jan 7PMID33413428doi:10.1186/s12933-020-01205-2via clinicaltrials gov reference derived + pubmed nct search
Liraglutide improves the beta-cell function without increasing insulin secretion during a mixed meal in patients, who exhibit well-controlled type 2 diabetes and coronary artery disease.
Diabetology & metabolic syndrome2019 (year)PMID31164926doi:10.1186/s13098-019-0438-6via clinicaltrials gov reference derived + pubmed nct search
Effects of the glucagon-like peptide-1 receptor agonist liraglutide on 24-h ambulatory blood pressure in patients with type 2 diabetes and stable coronary artery disease: a randomized, double-blind, placebo-controlled, crossover study.
Journal of hypertension2017 May (month)PMID28129251doi:10.1097/HJH.0000000000001275via clinicaltrials gov reference derived + pubmed nct search
Effects of Liraglutide on Heart Rate and Heart Rate Variability: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.
Diabetes care2017 Jan (month)PMID27797930doi:10.2337/dc16-1580via clinicaltrials gov reference derived + pubmed nct search
Effects of the glucagon-like peptide-1 receptor agonist liraglutide on systolic function in patients with coronary artery disease and type 2 diabetes: a randomized double-blind placebo-controlled crossover study.
Cardiovascular diabetology2016 Jul 26PMID27455835doi:10.1186/s12933-016-0425-2via clinicaltrials gov reference derived + pubmed nct search
Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes (the AddHope2 study): a randomised controlled study protocol.
BMJ open2014 Jul 16PMID25031198doi:10.1136/bmjopen-2014-005942via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.