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Completed

NCT Number: NCT01916174

A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female volunteers
  • Body mass index (BMI) between 18.5 and 27.0 kg/m^2 (both inclusive)
  • Body weight between 60 and 90 kg (both inclusive)

Exclusion criteria

  • Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, 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
  • 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
  • Drug or alcohol abuse

Treatment and study plan

insulin degludec/liraglutide

Drug

Subject will receive a single injection (s.c.) of IDegLira B5

Primary outcomes

  1. Area under the serum IDeg concentration time curve after single dose

    Time frame: Assessed from 0 to 120 hours

  2. Maximum observed serum IDeg concentration after single dose

    Time frame: Assessed from 0-120 hours

  3. Area under the plasma liraglutide concentration time curve after single dose

    Time frame: Assessed from 0-72 hours

  4. Maximum observed plasma liraglutide concentration after single dose

    Time frame: Assessed from 0-72 hours

Secondary outcomes

  1. Area under the serum IDeg concentration time curve after single dose

    Time frame: Assessed from 0-120 hours

  2. Time to maximum IDeg concentration

    Time frame: Assessed from 0-120 hours

  3. Terminal elimination half-life for IDeg after single dose

    Time frame: Assessed from 0-120 hours

  4. Area under the plasma liraglutide concentration time curve after single dose

    Time frame: Assessed from 0-72 hours

  5. Time to maximum plasma liraglutide concentration after single dose

    Time frame: Assessed from 0-72 hours

  6. Terminal elimination half-life of liraglutide after single dose

    Time frame: Assessed from 0-72 hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2013
Registry last updated
Nov 8, 2013

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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