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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761540
• Other study ID #: NN2211-3533
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2008
• Last updated: January 25, 2017
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)
• placebo
Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)
• liraglutide
Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)
• placebo
Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)
• liraglutide
Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)
• placebo
Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

References & Publications (1)

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing.		After 21 days of treatment
Secondary	AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1)		After 1 day of treatment
Secondary	Adverse events		After 21 days of treatment
Secondary	Hypoglycaemic events		After 21 days of treatment

External Links

•   Clinical Trials at Novo Nordisk