Status:
COMPLETED
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of th...
Eligibility Criteria
Inclusion
- Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)
- Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive)
- Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more
Exclusion
- Known or suspected hypersensitivity to trial products or related products
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the Investigator
- Any chronic disorder or severe disease which in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Key Trial Info
Start Date :
February 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01796366
Start Date
February 21 2013
End Date
August 19 2013
Last Update
March 1 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460