Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

A Randomised, Open-label, Single-centre, Two-period, Cross-over Trial Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: liraglutide

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, age 18-60 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m^2
• Bodyweight up to 130.0 kg (inclusive)
• HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
• History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial, as judged by the investigator
• Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial defined as screening
• Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine (120 mL), or 20 mL spirits)
• Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide 0.6 mg s.c. with FlexPen®	Drug: liraglutide; Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)
Experimental: Liraglutide 0.6 mg s.c. with the PDS290 pen-injector	Drug: liraglutide; Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose	0-72 hours following administration of 0.6 mg liraglutide
Maximum observed liraglutide plasma concentration after single dose	0-72 hours following administration of 0.6 mg liraglutide

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of treatment emergent adverse events (TEAEs)	From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN8022-4162; 2014-000216-34 (EudraCT Number); U1111-1152-1391 (Other Identifier: WHO)