Clinical trial NCT01916174: A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
Official title: A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the serum IDeg concentration time curve after single dose
timeFrame: Assessed from 0 to 120 hours
measure: Maximum observed serum IDeg concentration after single dose
timeFrame: Assessed from 0-120 hours
measure: Area under the plasma liraglutide concentration time curve after single dose
timeFrame: Assessed from 0-72 hours
measure: Maximum observed plasma liraglutide concentration after single dose
timeFrame: Assessed from 0-72 hours
Secondary outcomes:
measure: Area under the serum IDeg concentration time curve after single dose
timeFrame: Assessed from 0-120 hours
measure: Time to maximum IDeg concentration
timeFrame: Assessed from 0-120 hours
measure: Terminal elimination half-life for IDeg after single dose
timeFrame: Assessed from 0-120 hours
measure: Area under the plasma liraglutide concentration time curve after single dose
timeFrame: Assessed from 0-72 hours
measure: Time to maximum plasma liraglutide concentration after single dose
timeFrame: Assessed from 0-72 hours
measure: Terminal elimination half-life of liraglutide after single dose
timeFrame: Assessed from 0-72 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: