Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes
Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to assess the safety and
 tolerability (maximum tolerated dose) after single and multiple doses of NNC 90-1170
 (liraglutide) in healthy volunteers and in 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