Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Healthy

Eligibility:

MALE

18-45 years

Phase:

PHASE1

Brief Summary

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 (pharmacodynam...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

37 Patients enrolled

Trial Details

Trial ID

NCT00761540

Start Date

October 1 2008

End Date

December 1 2008

Last Update

January 26 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China, 100032