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

Obesity Clinical Trial

Official title:

A Randomised, Open-label, Single-centre, Two-period, Cross-over Trial Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207348
• Other study ID #: NN8022-4162
• Secondary ID: 2014-000216-34U1
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2014
• Last updated: December 8, 2016
• Start date: August 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose		0-72 hours following administration of 0.6 mg liraglutide	No
Primary	Maximum observed liraglutide plasma concentration after single dose		0-72 hours following administration of 0.6 mg liraglutide	No
Secondary	Number of treatment emergent adverse events (TEAEs)		From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2	No

External Links

•   Clinical Trials at Novo Nordisk