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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01507337
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Healthy	Drug: liraglutide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Jun 1, 2004
• Actual Study Completion Date: Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elderly	Drug: liraglutide; A single dose of 1 mg administered subcutaneously (under the skin)
Experimental: Young	Drug: liraglutide; A single dose of 1 mg administered subcutaneously (under the skin)

Outcome Measures

Primary Outcome Measures

1. Area under the liraglutide plasma concentration time curve (AUC 0-t) []

Secondary Outcome Measures

1. Area under the liraglutide plasma concentration time curve (AUC 0-infinity) []

2. Cmax, maximum liraglutide plasma concentration []

3. tmax, time to reach Cmax []

4. t½, terminal plasma elimination half-life []

5. Adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Berlin		Germany	14050

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01507337
• Other Study ID Numbers: NN2211-1327
• First Posted: Jan 10, 2012
• Last Update Posted: Jan 24, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Liraglutide

Study Results

No Results Posted as of Jan 24, 2017