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The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Medication regimen A-B-C | Experimental |
| |
| Arm 2: Medication regimen B-C-A | Experimental |
| |
| Arm 3: Medication regimen C-A-B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR011408 injection; HR011408 injection Placebo | Drug | Medication regimen-A: HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve of insulin aspart | From 0 to 30 mins after trial product administration |
| Measure | Description | 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 |
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Inclusion Criteria:
- Subjects had to meet all the following criteria to enrol this study
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:
3. Previous and anticipated concomitant treatments:
4. General information:
5. Any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Chen | Contact | +86-0518-82342973 | hong.chen@hengrui.com | |
| Yifan Li | Contact | +86-0518-82342973 | yifan.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230601 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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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.
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| NovoRapid®; HR011408 injection Placebo | Drug | Medication regimen-B: NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum |
|
| HR011408 injection Placebo; HR011408 injection | Drug | Medication regimen-C: HR011408 injection Placebo, ante cibum: HR011408 injection, post cibum |
|
| Number of subjects with adverse events and severity of adverse events | From first dose to the last visit, approximately 2 months |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |