Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers

NCT01507337 | Completed Phase 1

• 1 other identifier: NN2211-1327
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the liraglutide plasma concentration time curve (AUC 0-t)

Secondary Outcomes (5)

• Area under the liraglutide plasma concentration time curve (AUC 0-infinity)

• Cmax, maximum liraglutide plasma concentration

• tmax, time to reach Cmax

• t½, terminal plasma elimination half-life

• Adverse events

Study Arms (2)

Elderly

EXPERIMENTAL

Drug: liraglutide

Young

EXPERIMENTAL

Drug: liraglutide

Interventions

liraglutide DRUG

A single dose of 1 mg administered subcutaneously (under the skin)

Elderly; Young

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age, young subjects: age 18-45 years (both incl.)
• Age, elderly subjects: age at least 65 years
• Body Mass Index (BMI) 18-30 kg/m\^2 (both incl.)
• Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg
• Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg

You may not qualify if:

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator
• Impaired renal function
• Any clinically significant abnormal ECG (electrocardiogram)
• Active hepatitis B and/or active hepatitis C
• Positive HIV (human immunodeficiency virus) antibodies
• Febrile illness within 5 days prior to first administration of liraglutide
• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• Damholt B, Golor G, Wierich W, Pedersen P, Ekblom M, Zdravkovic M. An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. J Clin Pharmacol. 2006 Jun;46(6):635-41. doi: 10.1177/0091270006288215.

  PMID: 16707410 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: April 1, 2004
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

DE (1)