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Trial · Interventional

CompletedPhase 4Registry data

The Effect of Liraglutide on the Treatment of Coronary Artery Disease and Type 2 Diabetes

Short name AddHope2

NCTNCT01595789 (opens ClinicalTrials.gov in a new tab)Other idBBHAH-2011430Other id2011-005405-78

Overview

Status
Completed
Phase
Phase 4
Enrollment
41 participants (actual)
Sponsor
Haugaard, Steen Bendix, M.D., DMSc · Indiv
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
May 2012
Primary completion
Oct 2014
Completion
Jul 2015
First posted
10 May 2012 (estimated)
Last update posted
7 Mar 2017
Conditions
Coronary Artery Disease · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 4

    AddHope2

    NCT01595789

    May 2012 to Jul 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo + metformin

  • Active comparator

    Liraglutide + metformin

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Beta-cell function

    Time frame · after 12 weeks of intervention

    Registry description

    Beta-cell function (disposition index) as measured during an intravenous glucose tolerance test (By Bergman Minimal Model)

  2. LVEF

    Time frame · after 12 weeks of intervention

    Registry description

    Changes in LVEF assessed by dobutamine stress echocardiography

Secondary outcomes(10)
  1. Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test

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

  2. 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

    Registry description

    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)

  3. 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

  4. Non esterified fatty acids (NEFA)

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

    Registry description

    NEFA during FSIGT by use of NEFA minimal model

  5. Heart rate variability (HRV)

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

    Registry description

    HRV i.e. SDNN (standard deviation of all normal RR interval) assessed during HOLTER monitoring

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

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

    Registry description

    Maximal velocity of the myocardium in systole (s´) and in diastole (e´) during the dobutamine stress test

  7. 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

    Registry description

    Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec)

  8. ST-depression and ectopic activity

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

    Registry description

    ST-depression and ectopic activity assessed during 24h HOLTER monitoring

  9. Diurnal blood pressure

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

  10. Diastolic heart function (E/E*)

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

    Registry description

    Diastolic heart function (E/E\*) in rest and during stress

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Effects of liraglutide on diastolic function parameters in patients with type 2 diabetes and coronary artery disease: a randomized crossover study.

Kumarathurai et al. 2021Cardiovascular diabetologycited by 16

PMID 33413428PMC7791686DOI 10.1186/s12933-020-01205-2PUB-33413428

CC BY5 results

Indexing hint: Randomized controlled trial · 2017

8 results

Effects of Liraglutide on Heart Rate and Heart Rate Variability: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.

Kumarathurai et al. 2017Diabetes carecited by 76

PMID 27797930DOI 10.2337/dc16-1580PUB-27797930

Rights unknown8 results

Indexing hint: Randomized controlled trial · 2017

7 results

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.

Kumarathurai et al. 2017Journal of hypertensioncited by 30

PMID 28129251DOI 10.1097/hjh.0000000000001275PUB-28129251

Full text at the publisher7 results

Indexing hint: Randomized controlled trial · 2016

5 results

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.

Kumarathurai et al. 2016Cardiovascular diabetologycited by 41

PMID 27455835PMC4960858DOI 10.1186/s12933-016-0425-2PUB-27455835

CC BY5 results

Indexing hint: Randomized controlled trial · 2014

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.

Anholm et al. 2014BMJ opencited by 10

PMID 25031198PMC4401817DOI 10.1136/bmjopen-2014-005942PUB-25031198

Free to read · publisher termsCC BY-NC
Read at source

More studies

1 study on this page

PubMed tag: none · 2019

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.

Anholm et al. 2019Diabetology & metabolic syndromecited by 11

PMID 31164926PMC6543623DOI 10.1186/s13098-019-0438-6PUB-31164926

CC BY
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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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