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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: liraglutide

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507285

NN2211-1189

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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