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Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01473953
First received: November 2, 2011
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Liraglutide
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Number of treatment emergent adverse events (TEAE) reported based on clinical observations [ Time Frame: from first trial related activity (day 1) until completion of last post-treatment follow-up visit (day 21) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum concentration of liraglutide [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
  • Time to maximum concentration of liraglutide [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration curve in the period from the time of liraglutide-depot administration to infinity [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration curve in the first week following liraglutide-depot administration for subjects without liraglutide 6 mg/ml pre-treatment [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration curve in the first week following liraglutide-depot administration for subjects with liraglutide 6 mg/ml pre-treatment [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
  • Antibodies against liraglutide observed at pre-dose and at last follow-up [ Time Frame: Day 0 and day 21 ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Without liraglutide pre-treatment Drug: liraglutide-depot
Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.
Drug: placebo
Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).
Experimental: With liraglutide pre-treatment Drug: liraglutide-depot
Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.
Drug: liraglutide
Subjects will receive treatment for 3-4 weeks with liraglutide (6 mg/ml), injected s.c./subcutaneously (under the skin), before receiving treatment with liraglutide-depot.
Drug: placebo
Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 20 and 35 kg/m^2 (both inclusive) with a body weight of at least 60 kg
  • Apart from being obese (BMI above 30 kg/m^2) the subject has to be considered generally healthy

Exclusion Criteria:

  • Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
  • Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy
  • Prescription medicine and non-prescription medicine with few exceptions
  • Current and prior history of alcohol or drug abuse
  • Current smoking of more than 5 cigarettes per day
  • Mental incapacity, language barriers, or unwillingness to comply with the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473953

Locations
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Stine Just Maarbjerg Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01473953     History of Changes
Other Study ID Numbers: NN9223-3928, U1111-1123-0547
Study First Received: November 2, 2011
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013