To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo

NCT ID: NCT00761540

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A1

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)

A2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)

B1

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)

B2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)

C1

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)

C2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

liraglutide

Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)

Intervention Type DRUG

placebo

Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)

Intervention Type DRUG

liraglutide

Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)

Intervention Type DRUG

placebo

Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)

Intervention Type DRUG

liraglutide

Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)

Intervention Type DRUG

placebo

Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent obtained before any trial related activities
* Healthy Chinese male subjects
* Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive)
* Fasting plasma glucose less than 6.0 mmol/L
* Non-smoker

Exclusion Criteria

* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
* Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmHg systolic and/or 40 - 90 mmHg diastolic
* Pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV antibodies positive.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Jiang J, Zhang J, Jacobsen LV, Hu P. The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects. J Clin Pharmacol. 2011 Dec;51(12):1620-7. doi: 10.1177/0091270010389468. Epub 2011 Jan 27.

Reference Type RESULT
PMID: 21273395 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NN2211-3533

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study
NCT07163624 ACTIVE_NOT_RECRUITING PHASE2