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Completed

NCT Number: NCT00761540

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liraglutide

Drug

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

Placebo

Drug

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

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 29, 2008
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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