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

NCT ID: NCT01916174

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2 Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Insulin degludec/liraglutide, B5

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.

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

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

Insulin degludec/liraglutide, V2

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.

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

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

Interventions

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insulin degludec/liraglutide

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

Intervention Type DRUG

insulin degludec/liraglutide

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Neuss, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-005468-93

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1137-3809

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-4026

Identifier Type: -

Identifier Source: org_study_id