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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916174
• Other study ID #: NN9068-4026
• Secondary ID: 2012-005468-93U1
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2013
• Last updated: November 7, 2013
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• insulin degludec/liraglutide
Subject will receive a single injection (s.c.) of IDegLira B5
• insulin degludec/liraglutide
Subject will receive a single injection (s.c.) of IDegLira V2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum IDeg concentration time curve after single dose		Assessed from 0 to 120 hours	No
Primary	Maximum observed serum IDeg concentration after single dose		Assessed from 0-120 hours	No
Primary	Area under the plasma liraglutide concentration time curve after single dose		Assessed from 0-72 hours	No
Primary	Maximum observed plasma liraglutide concentration after single dose		Assessed from 0-72 hours	No
Secondary	Area under the serum IDeg concentration time curve after single dose		Assessed from 0-120 hours	No
Secondary	Time to maximum IDeg concentration		Assessed from 0-120 hours	No
Secondary	Terminal elimination half-life for IDeg after single dose		Assessed from 0-120 hours	No
Secondary	Area under the plasma liraglutide concentration time curve after single dose		Assessed from 0-72 hours	No
Secondary	Time to maximum plasma liraglutide concentration after single dose		Assessed from 0-72 hours	No
Secondary	Terminal elimination half-life of liraglutide after single dose		Assessed from 0-72 hours	No

External Links

•   Clinical Trials at Novo Nordisk