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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499108
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : February 2, 2015
Novo Nordisk A/S
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center Copenhagen

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 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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: liraglutide Phase 4

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
Study Start Date : August 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide
single-group study were participants recieve Liraglutide
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

Primary Outcome Measures :
  1. Change in ambulatory blood pressure [ Time Frame: 50 days ]
    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 Outcome Measures :
  1. Change in ECV [ Time Frame: 50 days ]
    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 ]
    Change in 24h BP, ECV, weight, arterial stiffness from day 49 to day 70th

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499108

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Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Peter Rossing
Novo Nordisk A/S
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Principal Investigator: Peter Rossing, MD Steno Diabetes Centes
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peter Rossing, Director of Research, Chief Physician, DMSc, Steno Diabetes Center Copenhagen Identifier: NCT01499108    
Other Study ID Numbers: 2011-005344-95
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: July 2013
Keywords provided by Peter Rossing, Steno Diabetes Center Copenhagen:
type 2 diabetes
kidney function
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists