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 - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00761540

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: liraglutide Drug: placebo	Phase I

Drug Information available for: Insulin Dextrose Liraglutide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	37
Study Start Date:	October 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: liraglutide Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)
A2: Placebo Comparator	Drug: placebo Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)
B1: Experimental	Drug: liraglutide Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)
B2: Placebo Comparator	Drug: placebo Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)
C1: Experimental	Drug: liraglutide Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)
C2: Placebo Comparator	Drug: placebo Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761540

Locations

China

Beijing, China, 100730

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Xu Hongfei, MD

Novo Nordisk (China) Pharmaceuticals Co., Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-3533
Study First Received:	September 26, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00761540
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Healthy
Insulin

ClinicalTrials.gov processed this record on January 14, 2009