Diabetes Mellitus. MedDRA version: 8,0 Level: PT Classification code 10012601
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject) • Subjects diagnosed with type 2 diabetes and treated with OAD(s) for at least three months • HbA1c: • 7.5-10.0 % (both inclusive) in subjects on OAD monotherapy • 7.0-10.0 % (both inclusive) in subjects on OAD combination therapy • Age 18-80 years, both inclusive (as allowed according to local guidelines for metformin and glimepiride treatment) • BMI = 45.0 kg/m2 At randomisation: • Daily use of 4 mg glimepiride and 2000 mg metformin for at least 3 weeks • Mean fasting plasma glucose (FPG) of 7.5-12.8 millimol (mmol)/ litre (L) both inclusive (135-230 mg/dL both inclusive) Are the trial subjects under 18? 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
Exclusion criteria: • Treatment with insulin within the last three months prior to the trial (except for short-term treatment with insulin in connection with intercurrent illness at the discretion of the Investigator) • Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper limit normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being the conclusive) • Impaired renal function defined as serum-creatinine = 135 µmol/L (= 1.5 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females (one retest analysed at the central laboratory within a week permitted with the result of the last sample being the conclusive) • Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (New York Heart Association (NYHA) class III and IV) at the discretion of the Investigator • Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator • Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator • Use of any drug (except for OADs), which in the Investigator’s opinion could interfere with the glucose level (e.g. systemic corticosteroids) • Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess and compare the effect on glycaemic control (as measured by HbA1c) of once daily administration of liraglutide in combination with glimepiride and metformin versus glimepiride and metformin combination therapy, and versus insulin glargine added to glimepiride and metformin combination therapy in subjects with type 2 diabetes.;Secondary Objective: •To assess and compare the effect on body weight •To assess and compare the effect on glycaemic control (fasting plasma glucose (FPG)) and 8-point plasma glucose profiles (self-measured)) •To assess and compare ß-cell function and fasting glucagon. The homeostasis model assessment (HOMA) will be used •To assess and compare lipid profiles •To assess and compare effect the on blood pressure Safety objectives •To assess and compare the incidence of hypoglycaemic episodes •To assess the safety and tolerability of liraglutide in combination with glimepiride and metformin •To assess formation of liraglutide antibodies Other objectives •To assess and compare cardiovascular effects •To assess and compare waist and hip circumference and waist-to-hip ratio ;Primary end point(s): •HbA1c | — |
Countries
Austria, Denmark, Finland, Italy, United Kingdom
Outcome results
None listed