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: • 7.0-10.0 % (both incl.) in subjects on OAD combination therapy • 7.0-11.0 % (both incl.) in subjects on OAD monotherapy • Age 18 – 80 years, both inclusive (as allowed according to local guidelines for metformin and glimepiride treatment) • BMI = 40.0 kg/m2 At randomisation: • Daily use of 2000 mg metformin for at least three weeks • Mean fasting plasma glucose of 7.0-12.8 millimol (mmol)/L both incl. (126-230 mg/dL both incl.) 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
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 of normal (ULN) (one retest analysed at the central laboratory within a week is permitted with the result from the last sample being 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 is permitted with the result from the last sample being conclusive). • Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (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 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 intend to become pregnant or are 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 three doses of liraglutide in combination with metformin versus metformin monotherapy versus metformin and glimepiride combination therapy in subjects with type 2 diabetes.;Secondary Objective: To assess and compare •the effect on body weight •the effect on glycaemic control •ß-cell function and fasting glucagon •lipid profiles •the effect on blood pressure Safety objectives; To assess •and compare incidences of hypoglycaemic episodes •the safety and tolerability of liraglutide in combination with metformin •the formation of liraglutide antibodies, if any Other objectives; To assess and compare •cardiovascular effect •waist and hip circumference and waist-to-hip ratio •the ß-cell sparing effect - additional for the subjects entering the extension treatment period In a subset of subjects: • Patient reported outcomes assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Impact of Weight on Quality of Life Questionnaire – Lite Version (IWQOL-Lite) • To assess and compare body composition (including fat distribution assessed by dual energy x-ray absorptiometry (DEXA) and abdominal axial computerised tomography (CT) scan slices);Primary end point(s): •HbA1c | — |
Countries
Belgium, Denmark, Germany, Hungary, Ireland, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed