Clinical trial NCT01507285: Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes
Official title: A Randomised, Double-blind, Placebo-controlled, Dose-escalation, Parallel-group, Single and Multiple Dosing Trial of NN90-1170 in Healthy Volunteers and Patients With Type 2 Diabetes to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Primary outcomes:
measure: Area under the Curve
Secondary outcomes:
measure: Cmax, maximum concentration
measure: tmax, time to maximum concentration
measure: t½, terminal half-life
measure: Adverse events
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Agerso H, Jensen LB, Elbrond B, Rolan P, Zdravkovic M. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia. 2002 Feb;45(2):195-202. doi: 10.1007/s00125-001-0719-z.