Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Diabetes

Treatments: Drug: HR011408 injection; HR011408 injection Placebo; Drug: NovoRapid®; HR011408 injection Placebo; Drug: HR011408 injection Placebo; HR011408 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06375031

HR011408-103

Details and patient eligibility

About

The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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:

3. have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator.

4. Have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening;

5. Proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.

6. Previous and anticipated concomitant treatments:

7. 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

8. 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.

9. General information:

10. Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent nicotine per day).

11. Previous participation in this study. Participation was defined as randomised.

12. Any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Arm 1: Medication regimen A-B-C

Experimental group

Treatment:

Drug: NovoRapid®; HR011408 injection Placebo

Drug: HR011408 injection Placebo; HR011408 injection

Drug: HR011408 injection; HR011408 injection Placebo

Arm 2: Medication regimen B-C-A

Experimental group

Treatment:

Drug: NovoRapid®; HR011408 injection Placebo

Drug: HR011408 injection Placebo; HR011408 injection

Drug: HR011408 injection; HR011408 injection Placebo

Arm 3: Medication regimen C-A-B

Experimental group

Treatment:

Drug: NovoRapid®; HR011408 injection Placebo

Drug: HR011408 injection Placebo; HR011408 injection

Drug: HR011408 injection; HR011408 injection Placebo