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

A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00761540

Enrollment

Registered

2008-09-29

Start date

2008-10-31

Completion date

2008-12-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGliraglutide

Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)

DRUGplacebo

Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Adverse events	After 21 days of treatment
Hypoglycaemic events	After 21 days of treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026