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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01499108
First received: December 12, 2011
Last updated: November 27, 2013
Last verified: July 2013

December 12, 2011
November 27, 2013
August 2012
July 2013   (final data collection date for primary outcome measure)
Change in ambulatory blood pressure [ Time Frame: 50 days ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01499108 on ClinicalTrials.gov Archive Site
  • Change in ECV [ Time Frame: 50 days ] [ Designated as safety issue: No ]
    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).
  • Washout analysis [ Time Frame: 21 ] [ Designated as safety issue: No ]
    Change in 24h BP, ECV, weight, arterial stiffness from day 49 to day 70th
Same as current
Not Provided
Not Provided
 
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes

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

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 effect on BP may be mediated by a decrease in arterial stiffness and central aortic pressure

Purpose Primary purpose

• To assess how quickly the antihypertensive effect of liraglutide treatment set in after initiation in patients with type 2 diabetes

Secondary objectives

  • To measure the effect of liraglutide treatment on natriuresis.
  • To measure the effect of liraglutide treatment on ECV
  • To measure the effect of liraglutide treatment on arterial stiffness
  • To measure weight change after initiation of liraglutide treatment
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Drug: liraglutide
Subcutaneous injection of liraglutide at doses of 0.6, 1.2, and 1.8 mg once daily during the 49 days duration of the study
Other Name: Victoza
Experimental: Liraglutide
single-group study were participants recieve Liraglutide
Intervention: Drug: liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
35
August 2014
July 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01499108
2011-005344-95
Yes
Peter Rossing, Steno Diabetes Center
Peter Rossing
Novo Nordisk A/S
Principal Investigator: Peter Rossing, MD Steno Diabetes Centes
Steno Diabetes Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP