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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00761540

First received: September 26, 2008

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 26, 2008

Last Updated Date

January 18, 2013

Start Date ^ICMJE

October 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing. [ Time Frame: After 21 days of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00761540 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1) [ Time Frame: After 1 day of treatment ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: After 21 days of treatment ] [ Designated as safety issue: Yes ]
Hypoglycaemic events [ Time Frame: After 21 days of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Healthy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A1
Intervention: Drug: liraglutide
Placebo Comparator: A2
Intervention: Drug: placebo
Experimental: B1
Intervention: Drug: liraglutide
Placebo Comparator: B2
Intervention: Drug: placebo
Experimental: C1
Intervention: Drug: liraglutide
Placebo Comparator: C2
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00761540

Other Study ID Numbers ^ICMJE

NN2211-3533

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Xu Hongfei, MD

Novo Nordisk (China) Pharmaceuticals Co., Ltd.

Information Provided By

Novo Nordisk

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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