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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Healthy; Diabetes
• Interventions: Drug: insulin degludec/liraglutide

• Registration Number: NCT01916174
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin degludec/liraglutide, B5	insulin degludec/liraglutide	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.
Insulin degludec/liraglutide, V2	insulin degludec/liraglutide	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.

Primary Outcome Measures

Name	Time	Method
Area under the serum IDeg concentration time curve after single dose	Assessed from 0 to 120 hours
Area under the plasma liraglutide concentration time curve after single dose	Assessed from 0-72 hours
Maximum observed serum IDeg concentration after single dose	Assessed from 0-120 hours
Maximum observed plasma liraglutide concentration after single dose	Assessed from 0-72 hours

Secondary Outcome Measures

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