Effects of liraglutide on pancreatic function in type 2 diabetic patients with secondary failure to oral hypoglycemic agents.

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-003335-63-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-20
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

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

Inclusion Criteria

• The subject must give signed informed consents before any trial-related activities. • Type 2 diabetic subjects • Age >30 years and <75 years old • HbA1c =8.0 and <= 9.5% • Fasting plasma glucose <= 140 mg/dl • BMI >25 Kg/m2 and <40 Kg/m2 • Currently treated with metformin and sulphnilurea • Ability to comply with the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Participation in any other clinical trial three month prior to trial entry • Pregnancy, breastfeeding or women of childbearing age who do not follow adequate contraception • Patients has taken other antidiabetic drugs in the three month prior to trial entry • Current systemic treatment with concomitant medication having a significant influence on an end-point e.g. corticosteroids, thiazides, ß-blockers or ACE-inhibitors. • Known or suspected history of drug or alcohol dependence. • Any other significant concomitant disease such as cardiovascular (heart failure, angina pectoris, recent (within the last 12 months) myocardial infarction) or symptomatic peripheral vascular disease, malignant, hepatic disease (ALT>2 times upper limit of normal), renal impairment (serum creatinine >1.5 mg/dl). • Known or suspected allergy to trial products • BMI =25 Kg/m2 or =40 Kg/m2 • Mental incapacity • Any disease or condition which the investigator feels would interfere with the trial

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine to which extent liraglutide can maintain ß-cell function in type 2 diabetic patients with secondary failure after an adequate period of good glycaemic control.;Secondary Objective: To compare the effects of liraglutide and sulphonylurea on glicaemic control (fasting plasma glucose, HbA1C).;Primary end point(s): ß-cell glucose sensitivity as derived from the OGTT test analyzed according to Mari et al.;Timepoint(s) of evaluation of this end point: at 64 and 66 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): parameters of glycaemic control (FPG, HbA1C), time of loss of glycaemic control after stopping insulin treatment and proxies of beta-cell function i.e. Rate sensitivity (referring to the magnitude of beta-cell to respond to changes in prevailing plasma glucose concentrations), Potentiation factor, Dose response Insulin Secretion Rate and HOMA-B;Timepoint(s) of evaluation of this end point: at 64 and 66 weeks