Comparison of Two Liraglutide Formulations in Healthy Volunteers

NCT ID: NCT01508897

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-28
• Study Completion Date: 2004-06-30

Brief Summary

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phase 2 formulation

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Single dose administered as subcutaneous injection

Phase 3 formulation

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Single dose administered as subcutaneous injection

Interventions

liraglutide

Single dose administered as subcutaneous injection

Intervention Type: DRUG

liraglutide

Single dose administered as subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
• Body Mass Index (BMI) of 18-27 kg/m^2 incl.

Exclusion Criteria

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the study, as judged by the investigator
• Impaired renal function
• Uncontrolled treated/untreated hypertension
• Any clinically significant abnormal ECG
• Active hepatitis B and/or active hepatitis C
• Positive HIV (human immunodeficiency virus) antibodies
• History of alcoholism or drug abuse during the last 12 months
• Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
• Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 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

Neu-Ulm, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

NN2211-1331

Identifier Type: -

Identifier Source: org_study_id