Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

NCT ID: NCT02207348

Last Updated: 2016-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-09-30

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.

Conditions

Metabolism and Nutrition Disorder; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liraglutide 0.6 mg s.c. with FlexPen®

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)

Liraglutide 0.6 mg s.c. with the PDS290 pen-injector

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)

Interventions

liraglutide

Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, age 18-60 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m^2
• Bodyweight up to 130.0 kg (inclusive)
• HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion Criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or 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 that might have impact on the trial, as judged by the investigator
• 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 defined as screening
• Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine (120 mL), or 20 mL spirits)
• Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2014-000216-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1152-1391

Identifier Type: OTHER

Identifier Source: secondary_id

NN8022-4162

Identifier Type: -

Identifier Source: org_study_id