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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01473953
First received: November 2, 2011
Last updated: October 11, 2013
Last verified: October 2013
  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: 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. A Randomised, Double-blind, Placebo-controlled Trial Investigating Subcutaneously Single Dose Escalation of a Sustained Release Formulation of Liraglutide Lysine in Healthy Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 0 and up to 21 days after treatment ] [ Designated as safety issue: No ]
    TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.


Secondary Outcome Measures:
  • Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot [ Time Frame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ] [ Designated as safety issue: No ]
  • Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot [ Time Frame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ] [ 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 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment [ Time Frame: 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose ] [ 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: 0 to 168 hours after dosing ] [ Designated as safety issue: No ]
  • Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) 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: Cohort 1a: Lira-depot 2.25 mg 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.
Experimental: Cohort 2a: Lira-depot 6.75 mg 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.
Experimental: Cohort 3a: Lira-depot 15 mg 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.
Experimental: Cohort 4a: Lira-depot 30 mg 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.
Placebo Comparator: Placebo 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 A/S
Investigators
Study Director: Stine Just Maarbjerg Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: 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
Results First Received: June 20, 2013
Last Updated: October 11, 2013
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 April 17, 2014