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Completed

NCT Number: NCT02207348

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)

Primary outcomes

  1. Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose

    Time frame: 0-72 hours following administration of 0.6 mg liraglutide

  2. Maximum observed liraglutide plasma concentration after single dose

    Time frame: 0-72 hours following administration of 0.6 mg liraglutide

Secondary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 4, 2014
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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