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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT00761540 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3533
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
37 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
Oct 2008
Primary completion
Dec 2008
Completion
Dec 2008
First posted
29 Sept 2008 (estimated)
Last update posted
26 Jan 2017 (estimated)
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph 1

    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

    NCT00761540

    Oct 2008 to Dec 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug
  • liraglutideDrug
  • placeboDrug
  • liraglutideDrug
  • placeboDrug

Arms6

  • Experimental

    A1

  • Placebo comparator

    A2

  • Experimental

    B1

  • Placebo comparator

    B2

  • Experimental

    C1

  • Placebo comparator

    C2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing.

    Time frame · After 21 days of treatment

Secondary outcomes(3)

  1. AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1)

    Time frame · After 1 day of treatment

  2. Adverse events

    Time frame · After 21 days of treatment

  3. Hypoglycaemic events

    Time frame · After 21 days of treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

7 results

The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects.

Jiang et al. 2011Journal of clinical pharmacologycited by 21

PMID 21273395DOI 10.1177/0091270010389468PUB-21273395

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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