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.


Eligibility Criteria:
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