Liraglutide Effects on Memory in Healthy Subjects

NCT ID: NCT01550653

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-12-31

Brief Summary

This study examines the hypothesis, that subcutaneous administration of liraglutide, an analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in healthy humans.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Liraglutide

See "Intervention"

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Subcutaneous self-administration of liraglutide(Victoza)by pen. The starting dose is 0.6 mg once daily(day 0 to 7), followed by 1.2 mg once daily (day 8 to 35).

Placebo

See "Intervention"

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

liraglutide

Subcutaneous self-administration of liraglutide(Victoza)by pen. The starting dose is 0.6 mg once daily(day 0 to 7), followed by 1.2 mg once daily (day 8 to 35).

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Victoza

Eligibility Criteria

Inclusion Criteria

• Male sex
• Age 18-35 years
• Body mass index between 19 and 25 kg/m2
• Non-smoker

Exclusion Criteria

• Receipt of any drug within 4 weeks prior to this trial
• Any known acute or chronic disease of the brain, heart, lung, kidney,liver, pancreas or gastrointestinal tract, any metabolic, endocrine or psychiatric disease.
• Brady- and Tachycardia, i.e. heart rate < 50 and > 90 beats per minute.
• Hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg).
• Hyperlipidemia (cholesterol, LDL, triglyceride > two times the upper reference limit based on analysis from the central laboratory)
• Impaired hepatic function measured as alanine aminotransferase (ALAT) > two times the upper reference limit based on analysis from the central laboratory
• Impaired renal function measured as creatinine > 120 µmol/l based on analysis from the central laboratory
• Family history of diabetes
• History of any eating disorder
• Known or suspected allergy to trial products
• History of drug or alcohol abuse within the last five years prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

University of Luebeck

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Volker Ott

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Volker Ott, MD

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck, Department of Neuroendocrinology

Locations

University of Luebeck, Department of Neuroendocrinology

Lübeck, , Germany

Countries

Germany

Other Identifiers

Ott-NN-001

Identifier Type: -

Identifier Source: org_study_id