Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes

Inclusion criteria

• HEALTHY VOLUNTEERS
• Healthy subjects aged 18-45 years inclusive
• Healthy subjects are defined as individuals free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results
• Women who are not of childbearing potential
• Signed and dated written informed consent obtained
• Body mass index (BMI) within the range 19-30 kg/m^2, inclusive
• SUBJECTS WITH DIABETES
• Subjects aged 40-70 years inclusive
• Subjects diagnosed with type-2 diabetes and a duration of diabetes of more than 12 months
• Women who are not of childbearing potential
• Signed and dated written informed consent obtained
• Fasting C-peptide at least 0.3 nmol/l and blood glucose at least 7 mmol/l
• Subjects currently on diet and/or OHA (oral hypoglycemic agents) for at least six months
• Body mass index (BMI) below 35 kg/m^2
• HbA1c (glycosylated haemoglobin) below 11%
• Stable on current medication for at least 3 weeks prior to dosing in this study

Exclusion criteria

• HEALTHY VOLUNTEERS
• Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation
• Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation
• Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous
• Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-150 mmHg systolic, 40-90 mmHg diastolic: heart rate 40-100 beats/min
• History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)
• Alcohol intake within 48 hours prior to visit
• Evidence of drug abuse on urine testing at study entry
• The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period
• Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
• History of significant drug allergy or drug hypersensitivity
• SUBJECTS WITH DIABETES
• Use of any drug (except for oral hypoglycaemic agents (OHAs)) which in the Investigator's opinion could interfere with the blood glucose level (e.g. insulin, systemic corticosteroids, thiazides)
• Recurrent severe hypoglycaemia as judged by the Investigator
• Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation
• Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation
• Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous
• Blood pressure and heart rate in seated position at the screening examination outside the ranges 110-160 mmHg systolic, 60-90 mmHg diastolic: heart rate 40-100 beats/min
• History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)
• Alcohol intake within 48 hours of visit
• Evidence of drug abuse on urine testing at study entry
• The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period
• Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies
• History of significant drug allergy or drug hypersensitivity