Time course of the blood pressure lowering effect of liraglutide therapy in type 2 diabetes

Phase 1

• Conditions: type 2 diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-005344-95-DK
• Lead Sponsor: Steno Diabetes Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-07
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.HbA1c > 6.5%
5.eGFR = 60 ml/min/1.73 m2 (estimated by MDRD formula)
6.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 oophorectomi or have been surgically sterilized or hysterectomised at least six months prior to screening
7.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
8.Patients must be on stable hypoglycemic medication for at least two weeks before the first visit.
9.Must be able to communicate with the investigator

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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)
15.The receipt of any investigational product 90 days prior to this trial
16.Known or suspected abuse of alcohol or narcotics
17.Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

Study & Design

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