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

NCT01499108 | Completed Phase 4 DMC

• 1 other identifier: 2011-005344-95
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; hypertension; liraglutide; kidney function

Outcome Measures

Primary Outcomes (1)

• Change in ambulatory blood pressure

  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

  50 days

Secondary Outcomes (2)

• Change in ECV

  50 days

• Washout analysis

  21

Study Arms (1)

Liraglutide

EXPERIMENTAL

single-group study were participants recieve Liraglutide

Drug: liraglutide

Interventions

liraglutide DRUG

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

Also known as: Victoza

Liraglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peter Rossing: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

• von Scholten BJ, Hansen TW, Goetze JP, Persson F, Rossing P. Glucagon-like peptide 1 receptor agonist (GLP-1 RA): long-term effect on kidney function in patients with type 2 diabetes. J Diabetes Complications. 2015 Jul;29(5):670-4. doi: 10.1016/j.jdiacomp.2015.04.004. Epub 2015 Apr 11.

  PMID: 25935863 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Peter Rossing, MD

  Steno Diabetes Centes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research, Chief Physician, DMSc

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 26, 2011
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2014
• Last Updated: February 2, 2015

Record last verified: 2013-07

Locations

DK (1)