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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 2, Healthy

Intervention / Treatment
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* Drug: insulin degludec/liraglutide
* Drug: insulin degludec/liraglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin degludec/liraglutide, B5<br>Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. | Drug: insulin degludec/liraglutide<br>* Subject will receive a single injection (s.c.) of IDegLira B5<br>|
| Experimental: Insulin degludec/liraglutide, V2<br>Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. | Drug: insulin degludec/liraglutide<br>* Subject will receive a single injection (s.c.) of IDegLira V2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum IDeg concentration time curve after single dose |  | Assessed from 0 to 120 hours | 
| Maximum observed serum IDeg concentration after single dose |  | Assessed from 0-120 hours | 
| Area under the plasma liraglutide concentration time curve after single dose |  | Assessed from 0-72 hours | 
| Maximum observed plasma liraglutide concentration after single dose |  | Assessed from 0-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum IDeg concentration time curve after single dose |  | Assessed from 0-120 hours | 
| Time to maximum IDeg concentration |  | Assessed from 0-120 hours | 
| Terminal elimination half-life for IDeg after single dose |  | Assessed from 0-120 hours | 
| Area under the plasma liraglutide concentration time curve after single dose |  | Assessed from 0-72 hours | 
| Time to maximum plasma liraglutide concentration after single dose |  | Assessed from 0-72 hours | 
| Terminal elimination half-life of liraglutide after single dose |  | Assessed from 0-72 hours |