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Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01515592
First received: January 18, 2012
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Adverse events
  • Body weight
  • Antibody against liraglutide

Secondary Outcome Measures:
  • Area under the plasma liraglutide concentration curve
  • Cmax, maximum concentration
  • tmax, time to reach Cmax
  • Terminal elimination rate constant
  • t½, terminal elimination half-life
  • 24-hour profiles of plasma glucose
  • 24-hour profiles of serum insulin

Enrollment: 24
Study Start Date: January 2006
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mcg/kg Drug: liraglutide
One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Experimental: 20 mcg/kg Drug: liraglutide
One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Experimental: 25 mcg/kg Drug: liraglutide
One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy Japanese subjects
  • BMI (Body Mass Index) between 18.0-27.0 kg/m^2 inclusive

Exclusion Criteria:

  • Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening
  • Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
  • Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
  • History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
  • History of significant allergy or hypersensitivity
  • Known or suspected allergy to trial product or related products
  • History of drug or alcohol abuse
  • The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515592

Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01515592     History of Changes
Other Study ID Numbers: NN2211-1694
Study First Received: January 18, 2012
Last Updated: January 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 22, 2017