Status:
COMPLETED
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
Lead Sponsor:
Peter Rossing
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 an...
Detailed Description
Hypotheses Primary hypothesis • Liraglutide treatment causes a reduction in 24h BP Secondary hypothesis: * The effect on BP may be mediated by an increase in natriuresis, thereby affecting ECV * The...
Eligibility Criteria
Inclusion
- 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
- Male or female patients \> 18 years with type 2 diabetes (WHO criteria).
- 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.
- eGFR ≥ 60 ml/min/1.73 m2 (estimated by MDRD formula)
- 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
- 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
- Patients must be on stable hypoglycemic medication for at least two weeks before the first visit.
- Must be able to communicate with the investigator
Exclusion
- Ongoing insulin therapy
- BP \> 170/105 mm Hg at baseline
- Type 1 diabetes mellitus
- 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 which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
- 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
- Inflammatory bowel disease
- 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
- Previous bowel resection
- Body mass index \<18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
- Clinical signs of diabetic gastroparesis
- Impaired liver function (transaminases \> two times upper reference levels)
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01499108
Start Date
August 1 2012
End Date
August 1 2014
Last Update
February 2 2015
Active Locations (1)
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1
Steno Diabetes Center
Gentofte Municipality, Denmark, 2820