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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: insulin degludec/liraglutide; Drug: insulin degludec/liraglutide

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: insulin degludec/liraglutide; Subject will receive a single injection (s.c.) of IDegLira B5; Drug: insulin degludec/liraglutide; Subject will receive a single injection (s.c.) of IDegLira V2
Experimental: 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.	Drug: insulin degludec/liraglutide; Subject will receive a single injection (s.c.) of IDegLira B5; Drug: insulin degludec/liraglutide; Subject will receive a single injection (s.c.) of IDegLira V2

What is the study measuring?

Primary Outcome Measures

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 Measures

Outcome Measure	Time Frame
Area under the plasma liraglutide concentration time curve after single dose	Assessed from 0-72 hours
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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 7, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Liraglutide; Xultophy
• Other Study ID Numbers: NN9068-4026; 2012-005468-93 (EudraCT Number); U1111-1137-3809 (Other Identifier: WHO)