Type 2 diabetes MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza®
Product Name: Victoza®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
St. Josef-Hospital, Ruhr University, Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish, whether liraglutide improves the glucagon concentration under hypoglycaemic conditions in patients with type 2 diabetes;Secondary Objective: To establish, whether liraglutide treatment 1) increases the amplitude and mass of pulsatile glucagon secretion in response to hypoglycaemia 2) reduces the amplitude and mass of pulsatile glucagon secretion in response to oral glucose 3) increases the amplitude and mass of pulsatile insulin secretion in response to oral glucose 4) improves the interaction between pulsatile insulin and glucagon secretion ;Primary end point(s): Concentrations of insulin, C-peptide and glucagon * before and after treatment with liraglutide or placebo * between euglycaemic and hypoglycaemic periods within the clamp experiment ;Timepoint(s) of evaluation of this end point: Before and after 56 days treatment with study drug/placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Cortisol levels in the course of the clamp experiment 2. Growth hormone (GH) levels in the course of the clamp experiment 3. Adrenaline levels in the course of the clamp experiment 4. Noradrenaline levels in the course of the clamp experiment ;Timepoint(s) of evaluation of this end point: Before and after 56 days treatment with study drug/placebo | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Juris J Meier
Outcome results
None listed