Status:
COMPLETED
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/l...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male and female Chinese subjects, who are considered to be generally healthy, based on assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator
- Age between 18 to 45 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 19.0 and 24.0 kg/sqm (both inclusive)
- Body weight at least 50.0 kg
- Fasting plasma glucose less than 6.1 mmol/L (110 mg/dL)
- Exclusion criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive methods throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
- Donation of any blood or plasma in the past month or in excess of 400 mL within the 90 days preceding screening or surgery or trauma with more than 400 mL blood loss within the 90 days preceding screening
- History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes and recurrent hypoglycaemia), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial result, as judged by the investigator
- Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (mega-dose vitamin therapy not allowed, dose judged by the investigator) within 2 weeks prior to screening
Exclusion
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03292185
Start Date
September 29 2017
End Date
January 2 2018
Last Update
November 18 2019
Active Locations (1)
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1
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China, 100032