The influence of liraglutide on hypoglycaemia counterregulation and insulin secretion in type 2 diabetics

• Conditions: Type 2 diabetes; MedDRA version: 14.1Level: 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: EUCTR2010-023107-10-DE
• Lead Sponsor: St. Josef-Hospital, Ruhr University, Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-29
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

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

Inclusion Criteria

• Type 2 diabetes mellitus (at least 6 months) based on the disease diagnostic criteria WHO) classification
• In case of existing therapy with sulfonlyurea or DPP 4–inhibitors agreement to pause the medication 4 weeks before visit 3 takes place and during the study.
• Men or women from 18 to 70 years, inclusive

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

• Any contraindications, known allergy / hypersensitivity to liraglutide or another GLP-1 analogue or excipients contained in these products.
• Participation in an interventional medical, surgical or pharmaceutical study within the last three months prior to entry into the study
• Any other condition that may preclude the patient from following and completing the protocol
• Patients with type 1 diabetes mellitus
• Women of child-bearing age, who are pregnant, plan a pregnancy or do not use a sufficient method of contraception (sterilisation, intrauterine hormone application, oral contraceptives, sexual abstinence or vasectomised partners).
• Any evidence that the patient will probably not comply with the trial protocol (e.g. lack of willingness to cooperate)
• Pharmacotherapy with digoxin, lisinopril, warfarin, insulin, GLP-1 analogues
• Patients with moderate and severe renal impairment (creatinine clearance < 59 ml/min)
• Impaired liver function (GOT and/or GPT 3x ULN)
• History of benign/malign thyroid tumours
• History of chronic pancreatitis/idiopathic acute pancreatitis
• Cardiac insufficiency NYHA stage I – IV
• Manifest CHD; history of myocardial infarction
• Chronic inflammatory enteropathy
• Diabetic gastroparesis
• Patients with known haemoglobinopathy or chronic anaemia (Hb < 10 mg/dl)
• Patients on systemic glucocorticoid treatment (except topic or inhalative preparations) within the last 3 months prior to screening
• History of thrombosis/embolism, coagulation disorders
• Alcohol abuse
• Oncologic disease (except basal cell Ca and squamous cell carcinoma of the skin)

Study & Design

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