Clinical trial NCT00761540: To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo
Official title: A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial related activities
* Healthy Chinese male subjects
* Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive)
* Fasting plasma glucose less than 6.0 mmol/L
* Non-smoker

Exclusion Criteria:

* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
* Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmHg systolic and/or 40 - 90 mmHg diastolic
* Pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV antibodies positive.

Primary outcomes:
measure: AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing.
timeFrame: After 21 days of treatment
Secondary outcomes:
measure: AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1)
timeFrame: After 1 day of treatment
measure: Adverse events
timeFrame: After 21 days of treatment
measure: Hypoglycaemic events
timeFrame: After 21 days of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Jiang J, Zhang J, Jacobsen LV, Hu P. The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects. J Clin Pharmacol. 2011 Dec;51(12):1620-7. doi: 10.1177/0091270010389468. Epub 2011 Jan 27.