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
  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
Diabetes
Healthy
Drug: liraglutide
Drug: placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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
Experimental: A1 Drug: liraglutide
Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)
Placebo Comparator: A2 Drug: placebo
Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)
Experimental: B1 Drug: liraglutide
Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)
Placebo Comparator: B2 Drug: placebo
Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)
Experimental: C1 Drug: liraglutide
Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)
Placebo Comparator: C2 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
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Xu Hongfei, MD Novo Nordisk (China) Pharmaceuticals Co., Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00761540     History of Changes
Other Study ID Numbers: NN2211-3533
Study First Received: September 26, 2008
Last Updated: January 18, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014