Safety and efficacy of liraglutide as add-on to insulin and metformin therapy in type 2 diabetes patients - Lira-Pro pilot

• Conditions: type 2 diabetes; MedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2010-019956-32-DK
• Lead Sponsor: Allan Vaag, Steno Diabetes Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Subjects diagnosed with type 2 diabetes
•=18 years of age
•HbA1C=8.0%
•BMI=27 kg/m2
•Treatment: Use of more than 1 unit insulin per kilogram body weight daily. Patients should have been treated with insulin and metformin for more than four months. Patients included should not be on other anti-diabetic combinations than insulin and metformin. Patients using antihypertensive, lipid-lowering, and/or anti-coagulation (acetylsalicylic acid) drugs are allowed to continue their treatment during the study period.

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

Exclusion Criteria

•Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
•Impaired kidney function (estimated GFR below 60 ml/min/1.73m2)
•Impaired liver function (p-ALAT level higher than 3 x upper normal limit)
•Cancer or any clinically significant disease or disorder as judged by the investigator
•History of chronic pancreatitis or idiopathic pancreatitis
•History of heart disease: acute myocardial infarct, stroke, congestive heart failure, (unstable) angina pectoris. Previously unknown abnormalities in cardiac function discovered at the baseline examination may result in exclusion of the patient from the study (judged by the investigator)
•Left ventricular ejection fraction < 45%
•Family history of thyroid diseases
•Atrial fibrillation or flutter
•Intra-ventricular conduction block
•Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion
•Pregnant or lactating women
•Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implantation hormonal vaginal ring, transdermal application, or intra-uterine devices
•Allergic to one or more of the medications used in the study
•Treatment with peroral steroids
•Concomitant participation in other intervention study – judged by the investigator
•Unable to understand the informed consent and the study procedures
•Participation in other intervention studies at time of inclusion or within three months prior to inclusion – judged by the investigator

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Change in HbA1c from baseline to twelve weeks.;Main Objective: To study the safety and efficacy of adding the GLP-1 analogue liraglutide (Victoza®) to current treatment with insulin and metformin in poorly regulated and overweight patients with type 2 diabetes. ;Secondary Objective: To study the effect of liraglutide (Victoza®) on changes in left ventricular function and mass, 24-hours mean blood pressure, glomerular filtration rate, body weight, insulin dose, 24-h glucose profiles, number of adverse events, minor and major hypoglycaemic episodes, nausea and other gastrointestinal disturbances.