Actively Recruiting
Comparison of HR011408 and NovoRapid® in Subjects With Diabetics
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2024-05-21
30
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics.
CONDITIONS
Official Title
Comparison of HR011408 and NovoRapid® in Subjects With Diabetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-64 years (both inclusive)
- Body mass index 18.5-35.0 kg/m2 (both inclusive)
- Diagnosed with type 1 or type 2 diabetes for at least 12 months at screening
- HbA1c 9.0% or lower by local laboratory at screening
- Currently treated with basal-bolus insulin regimen or continuous subcutaneous insulin infusion for at least 8 weeks
- For type 2 diabetes, stable dose of metformin for at least 8 weeks
- Total daily insulin treatment less than 1.2 U/kg/day
- Total daily bolus insulin treatment between 0.3 and 0.7 U/kg/day
You will not qualify if you...
- Poor blood pressure control with systolic ≥160 mmHg or diastolic ≥100 mmHg
- History of severe hypoglycemia episodes within 6 months before screening
- Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening
- Proliferative retinopathy, maculopathy, or severe neuropathy including autonomic neuropathy
- Unable or unwilling to avoid herbal products and non-routine vitamins within 14 days or 5 half-lives before dosing
- Use of routine vitamins within 48 hours prior to trial product administration
- Participation in any investigational drug or therapy trial within 1 month or 5 half-lives before screening
- Smoking more than 5 cigarettes or equivalent nicotine per day
- Previous participation in this study as a randomized subject
- Any other condition judged by the investigator to risk subject safety or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
Research Team
H
Hong Chen
CONTACT
Y
Yifan Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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