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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source 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.

Overall Status Completed
Start Date August 2013
Completion Date November 2013
Primary Completion Date November 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure 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
Measure 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
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: insulin degludec/liraglutide

Description: Subject will receive a single injection (s.c.) of IDegLira B5

Arm Group Label: Insulin degludec/liraglutide, B5

Intervention Type: Drug

Intervention Name: insulin degludec/liraglutide

Description: Subject will receive a single injection (s.c.) of IDegLira V2

Arm Group Label: Insulin degludec/liraglutide, V2

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Location Countries

Germany

Verification Date

November 2013

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Insulin degludec/liraglutide, B5

Type: Experimental

Description: 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.

Label: Insulin degludec/liraglutide, V2

Type: Experimental

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov