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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: placebo; Drug: liraglutide

• Registration Number: NCT00761540
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Study Start: 2008-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	placebo	-
B2	placebo	-
C2	placebo	-
A1	liraglutide	-
B1	liraglutide	-
C1	liraglutide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Beijing, Beijing, China