Diabetes
Conditions
Brief summary
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics.
Interventions
DRUGHR011408 injection; HR011408 injection Placebo
Medication regimen-A: HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum
DRUGNovoRapid®; HR011408 injection Placebo
Medication regimen-B: NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum
DRUGHR011408 injection Placebo; HR011408 injection
Medication regimen-C: HR011408 injection Placebo, ante cibum: HR011408 injection, post cibum
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The study was designed as a multi-center, randomized, double-blind, three-cycle crossover, positive drug control (NovoRapid ®) To compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single injection of HR011408 or NovoRapid ® before or after a standard meal test in patients with type 1 or type 2 diabetes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
\- Subjects had to meet all the following criteria to enrol this study 1. Male or female aged 18-64 years (both inclusive)； 2. Body mass index 18.5-35.0 kg/m2 (both inclusive)； 3. Diagnosed with type 1 diabetes or type 2 diabetes≥ 12 months at screening； 4. HbA1c ≤9.0% by local laboratory at screening； 5. Current treatment with any basal-bolus insulin regimen or continuous subcutaneous insulin infusion(CSII) for ≥ 8 weeks. Patients with type 2 diabetes can also take metformin but require a stable metformin dose for ≥8 weeks； 6. Current total daily insulin treatment \< 1.2 U/kg/day, and total daily bolus insulin treatment ≥ 0.3 U/kg/day and \< 0.7 U/kg/day.
Exclusion criteria
\- Subjects who meet any of the following criteria will be excluded from this study. 1\. The following laboratory or ancillary abnormalities were present from screening until randomization: 1\) Poor blood pressure control, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg. 2\. Subject has any history or evidence meet the following diseases or conditions: 1. have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator. 2. Have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening; 3. Proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator. 3\. Previous and anticipated concomitant treatments: 1. Not able or willing to refrain from any use of herbal products and non-routine vitamins within 14 days or within 5 half-lives (whichever is longer), and routine vitamins within 48 hours prior to trial product administration 2. Within 1 month or have within 5 half-lives (whichever is longer) participated in any trail (defined participate in trail as having had randomized) of using investigational drug or therapy prior to screening. 4\. General information: 1. Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent nicotine per day). 2. Previous participation in this study. Participation was defined as randomised. 5\. Any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum concentration-time curve of insulin aspart | From 0 to 30 mins after trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum concentration-time curve of insulin aspart | From 0 to 6 hours after trial product administration |
| Plasma glucose concentration | From 0 to 6 hours after start of a standardised meal |
| Number of subjects with adverse events and severity of adverse events | From first dose to the last visit, approximately 2 months |
Countries
China
Contacts
Primary ContactHong Chen
Backup ContactYifan Li
Outcome results
None listed