The effect of liraglutide on arterial blood pressure in hypertensive patients with type 2 diabetes mellitus

Phase 1

• Conditions: Hypertention, Type 2 Diabetes; MedDRA version: 17.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 17.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-002348-99-GR
• Lead Sponsor: Aristotle University Thessaloniki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-14
• Study Completion: 2017-07-19
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1.Type 2 diabetes mellitus
2.Age >18 years
3.Patients on stable antihyperglycaemic treatment for at least 12 weeks prior to recruitment. Stable treatment is considered stable medication and dose.
4.HbA1c: 7.5%-10%
5.Patients with prehypertension or stage 1 hypertension (JNC7) [1], on stable antihypertensive agent treatment for at least 6 weeks prior to the start of the study.
6.Prior to randomisation, on visit 1 and visit 2a, patients must have:
a.mean sitting systolic BP (SBP) >95 and <160 mmHg,
b.mean sitting diastolic BP (DBP) >50 and <100 mmHg,
c.a decrease in SBP of <20 mmHg or increase in heart rate (HR) of <30 beats per min (bpm) when standing from the sitting position, and
d.a pulse rate >40 bpm in the sitting position
7.Creatinine clearance =60 mL/min
8.Good clinical condition as determined by medical history, vital signs, ECG, physical examination, laboratory tests (haematology, chemistry, urine analysis)
9.Ability to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Patients who used insulin, a GLP-1 agonist or a DPP-4 inhibitor during the previous 3 months
2.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). A pregnancy test will be performed in women with childbearing potential during the V1.
3.Night shift workers who sleep during the daytime
4.History of drug or alcohol dependency
5.Hepatic or renal dysfunction
a.SGOT (ALT) or SGPT (AST) >2 times the upper limit of normal
b.Creatinine clearance <60 mL/ min
6.Lipase >= 3 x UNL
7.Hypersensitivity to trial drug or similar
8.Previous history of pancreatitis
9.Type 1 diabetes, familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma, personal history of non-familial medullary thyroid carcinoma
10.History or presence of immunological or haematological disorders
11.Known or suspected secondary hypertension
12.Medication that may affect BP (steroids/NSAIDs)
13.Upper arm circumference >42 cm
14.Any clinical condition that would not allow safe completion of the protocol according to investigators opinion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: A randomised, double blind, placebo-controlled study in patients with type 2 diabetes mellitus (T2DM), investigating the effect of liraglutide on blood pressure (BP), assessed by 24 h ambulatory blood pressure monitoring (ABPM).;Secondary Objective: Not applicable;Primary end point(s): The primary end point is the difference in the change of mean 24 h SBP between the two groups (liraglutide and placebo).;Timepoint(s) of evaluation of this end point: At the end of trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Difference in the change in mean daytime and mean night time SBP and DBP and heart rate between the two groups<br>2.Difference in the change in weight between the two groups<br>3.Difference in the change in renal sodium handling (sodium fractional excretion [FENa], proximal and distal sodium reabsorption) between the two groups<br>4.Difference in the changes in glycaemic control (assessed by HbA1c and fasting blood glucose) and insulin sensitivity (HOMA%S) between the two groups<br>5.Difference in the change of antihypertensive medication necessary to treat in accordance to the current medical practice and the related guidelines;Timepoint(s) of evaluation of this end point: At the end of trial