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Trial · Interventional

CompletedPhase 4Registry data

Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus

NCTNCT01208012 (opens ClinicalTrials.gov in a new tab)Other idLira-Vasc-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
44 participants (actual)
Sponsor
ikfe-CRO GmbH · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
Apr 2010
Primary completion
Nov 2010
Completion
Nov 2010
First posted
23 Sept 2010 (estimated)
Last update posted
15 Mar 2011 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011
  1. Ph 4

    Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus

    NCT01208012

    Apr 2010 to Nov 2010

Registry summary

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

The trial is a phase IV clinical trial investigating the impact of Liraglutide on endothelial function and microvascular blood flow in 44 patients with type 2 diabetes mellitus aged 30-65 and HbA1c ranging from ≥ 5.5% ≤ 7.0%. The patients will be randomized into two study arms, one arm will be treated with Metformin monotherapy, the second arm will be treated with Metformin and Liraglutide at an increasing dose (0.6 mg/day to 1.8 mg/day.)

Interventions

  • Victoza®Drug

Arms2

  • No intervention

    Metformin

    Patients taking Metformin at individual dose

  • Experimental

    Metformin and Liraglutide

    Patients taking Metformin at individual dose and Liraglutide 0.6 mg once daily for the 1st week, 1.2 mg daily for another 5 weeks, 1.8 mg daily for another 6 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The difference in increase of retinal blood flow after flicker stimulation of retinal endothelial cells

    Time frame · timepoint 0 and after 6 and 12 weeks

    Registry description

    Retinal capillary blood flow will be assessed using scanner laser doppler flowmetry.

Secondary outcomes(9)

  1. Central vascular elasticity

    Time frame · timepoint 0 and after 6 and 12 weeks

    Registry description

    Central arterial elasticity will be measured by Pulse wave velocity.

  2. Skin endothelial function and Skin oxygenation

    Time frame · timepoint 0 and after 6 and 12 weeks

    Registry description

    Microvascular skin blood flow and postcapillary tissue oxygenation (sO2)will be measured.

  3. Blood glucose control

    Time frame · timepoint 0 and after 6 and 12 weeks

    Registry description

    Fasting plasma glucose will be measured.

  4. Blood glucose control

    Time frame · up to 2 weeks before baseline and after 6 and 12 weeks after baseline

    Registry description

    HbA1c will be maesured.

  5. Change of biomarkers of sub-clinical inflammation and cardiovascular risk

    Time frame · timepoint 0 and after 6 and 12 weeks

    Registry description

    Biomarkers PAI-1, hsCRP, VCAM, E-selectin and ADMA will be measured.

  6. Change of biomarker of heart failure

    Time frame · timepoint 0 and after 6 and 12 weeks

    Registry description

    NT-pro BNP will be measured.

  7. Insulin/ intact Proinsulin ratio, C-peptide

    Time frame · timepoint 0 and after 6 and 12 weeks

    Registry description

    Insulin Intact Proinsulin and C-peptide will be maesured.

  8. Change of body weight

    Time frame · up to 2 weeks before baseline and after 6 and 12 weeks after baseline

    Registry description

    Body weight will be measured.

  9. Safety evaluation

    Time frame · up to 2 weeks before baseline and after 12 weeks post baseline

    Registry description

    The safety evaluation includes: * Metabolic parameters indicating hepatic function (ALAT, ASAT, γ-GT) * Blood analysis (Alkaline Phosphatase, Blood cell count) * Change in pancreas function (Amylase, Lipase) * Change in renal function (Creatinine, Potassium) * Change in thyroid function (Calcitonin) * Vital signs (Blood Pressure, Radial Pulse, ECG) * β-HCG (only female patients of childbearing potential) * Adverse Events * Adverse Drug Reactions

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

10 results

Addition of liraglutide in patients with Type 2 diabetes well controlled on metformin monotherapy improves several markers of vascular function.

Forst et al. 2012Diabetic medicine : a journal of the British Diabetic Associationcited by 61

PMID 22288732DOI 10.1111/j.1464-5491.2012.03589.xPUB-22288732

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Diabetes Mellitus type 2 2. HbA1c ≥ 5.5% and ≤ 7.0% 3. Treatment with Metformin (daily dose 500 - 3000 mg monotherapy, the past 3 months) 4. Age 30 - 65 years Exclusion Criteria: 1. Pre-treatment with PPAR gamma agonists or DPP IV inhibitors or GLP-1 analogues within the last three months 2. History of type 1 Diabetes Mellitus 3. No full legal mental and physical ability to give informed consent 4. Uncontrolled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 90 mmHg) 5. Anamnestic acute and chronic infections 6. Inflammatory bowel disease and/or diabetic gastroparesis 7. Anamnestic history of epilepsy 8. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures 9. History of severe or multiple allergies 10. Treatment with any other investigational drug within 3 months before trial entry 11. Progressive fatal disease 12. History of drug or alcohol abuse in the past 2 years 13. Liver disease with ASAT or ALAT above 3 times the upper normal limit 14. Serum potassium \> 5.5 mmol/L 15. Moderate to Severe Kidney disease with a GFR ≤ 60 ml/min 16. Pregnancy or breast feeding 17. Sexually active woman of childbearing potential not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner 18. Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 months prior to screening visit 19. History of dehydration, diabetic precoma, diabetic ketoacidosis or diabetic gastroparesis 20. Acute (within the previous 2 days) or scheduled investigation with iodine containing radiopaque material 21. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 6 months 22. Anamnestic uncontrolled unstable angina pectoris, pericarditis, myocarditis, endocarditis, haemodynamic relevant aortic stenosis, aortic aneurysma or heart insufficiency NYHA III or IV 23. Anamnestic recent pulmonary embolism or pulmonary insufficiency 24. Smoking within the last 6 months (\> 1 cigarette/day) 25. Planned change in antidiabetic, lipid lowering or blood pressure medication

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