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Trial · Interventional

CompletedPhase 4Registry data

Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes

Short name Liratime

Overview

Status
Completed
Phase
Phase 4
Enrollment
32 participants (actual)
Sponsor
Peter Rossing · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Denmark

Start
Aug 2012
Primary completion
Jul 2013
Completion
Aug 2014
First posted
26 Dec 2011 (estimated)
Last update posted
2 Feb 2015 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 4

    Liratime

    NCT01499108

    Aug 2012 to Aug 2014

Registry summary

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

Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential. The time course and the mechanism behind this effect are unknown. Objectives: To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes Design: Open-label study with intervention and subsequent washout period Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2 diabetes. Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once daily for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide treatment. Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV

Interventions

  • liraglutideDrug

Arms1

  • Experimental

    Liraglutide

    single-group study were participants recieve Liraglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in ambulatory blood pressure

    Time frame · 50 days

    Registry description

    Change in 24h BP from day 1 to day 49 (baseline to end of treatment) and time to statistically significant change in BP 24h after initiation of or increased dose of liraglutide

Secondary outcomes(2)
  1. Change in ECV

    Time frame · 50 days

    Registry description

    Changes in ECV (measured by GFR), urinary sodium, weight, arterial stiffness and daily home-BP, from day 1 to day 49 (baseline to end of treatment).

  2. Washout analysis

    Time frame · 21

    Registry description

    Change in 24h BP, ECV, weight, arterial stiffness from day 49 to day 70th

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: Clinical trial · 2015

4 results

Glucagon-like peptide 1 receptor agonist (GLP-1 RA): long-term effect on kidney function in patients with type 2 diabetes.

von Scholten et al. 2015Journal of diabetes and its complicationscited by 53

PMID 25935863DOI 10.1016/j.jdiacomp.2015.04.004PUB-25935863

Full text at the publisher4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee 2. Male or female patients \> 18 years with type 2 diabetes (WHO criteria). 3. Patients must be on treatment with metformin. Any form of treatment with SU compounds will be discontinued and washed out for two weeks prior to the start of study drug. 4. eGFR ≥ 60 ml/min/1.73 m2 (estimated by MDRD formula) 5. Fertile female patients must use chemical, hormonal and mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening 6. Patients must be on antihypertensive treatment or having elevated blood pressure (SBP ≥130 mm Hg and DBP ≥80 mmHg), lower than 170/105 mm Hg at baseline and the patients must be stable antihypertensive medication for at least 4 weeks prior to baseline 7. Patients must be on stable hypoglycemic medication for at least two weeks before the first visit. 8. Must be able to communicate with the investigator Exclusion Criteria: 1. Ongoing insulin therapy 2. BP \> 170/105 mm Hg at baseline 3. Type 1 diabetes mellitus 4. Chronic pancreatitis / previous acute pancreatitis 5. Known or suspected hypersensitivity to trial product(s) or related products. 6. Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening 7. Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial 8. Inflammatory bowel disease 9. Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months 10. Previous bowel resection 11. Body mass index \<18.5 kg/m2 12. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods 13. Clinical signs of diabetic gastroparesis 14. Impaired liver function (transaminases \> two times upper reference levels)

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