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

NCT02207348 | Completed Phase 1

• 3 other identifiers: NN8022-41622014-000216-34U1111-1152-1391
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• Maximum observed liraglutide plasma concentration after single dose

  0-72 hours following administration of 0.6 mg liraglutide

Secondary Outcomes (1)

• 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

Study Arms (2)

Liraglutide 0.6 mg s.c. with FlexPen®

EXPERIMENTAL

Drug: liraglutide

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

EXPERIMENTAL

Drug: liraglutide

Interventions

liraglutide 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 FlexPen®; Liraglutide 0.6 mg s.c. with the PDS290 pen-injector

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 4, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 9, 2016

Record last verified: 2016-12

Locations

DE (1)