Status:
COMPLETED
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ingr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01916174
Start Date
August 1 2013
End Date
November 1 2013
Last Update
November 8 2013
Active Locations (1)
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1
Neuss, Germany, 41460