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 A/S
ClinicalTrials.gov Identifier:
NCT00761540
First received: September 26, 2008
Last updated: January 18, 2013
Last verified: January 2013

September 26, 2008
January 18, 2013
October 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00761540 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Healthy
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00761540
NN2211-3533
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Xu Hongfei, MD Novo Nordisk (China) Pharmaceuticals Co., Ltd.
Novo Nordisk A/S
January 2013

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