A research study of a new medicine NNC0519-0130 in Japanese and non-Japanese men
Completed
- Conditions
- type 2 diabetes
- Registration Number
- jRCT2071230015
- Lead Sponsor
- Novo Nordisk Pharma Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 70
Inclusion Criteria
- Body mass index (BMI) between 23.0 kg/m2 and 39.9 kg/m2 (both inclusive) at screening with a minimum weight of 50 kg. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria
- Any disorder, which in the investigator opinion might jeopardise safety of participant or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, GI, or endocrinological conditions.
- HbA1c >= 6.5 % (48 mmol/mol) at screening. -Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period after the last dose in each treatment period Area under the NNC0519-0130 plasma concentration-time curve
Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period after the last dose in each treatment period Maximum plasma concentration of NNC0519-0130
Terminal half-life of NNC0519-0130 after the last dose after the last dose Terminal half-life of NNC0519-0130
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of NNC0519-0130 in type 2 diabetes management?
How does NNC0519-0130 compare to GLP-1 receptor agonists in glycemic control efficacy?
Which biomarkers correlate with NNC0519-0130's pharmacokinetic profiles in diabetic patients?
What adverse events are associated with NNC0519-0130's oral and subcutaneous administration routes?
Are there combination therapies involving NNC0519-0130 and SGLT2 inhibitors for type 2 diabetes?