Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

Phase 1

Recruiting

• Conditions: Diabetes
• Interventions: Drug: HR011408 injection; HR011408 injection Placebo; Drug: NovoRapid®; HR011408 injection Placebo; Drug: HR011408 injection Placebo; HR011408 injection

• Registration Number: NCT06375031
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Status Verified: 2024-05
• Study Start: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 3: Medication regimen C-A-B	HR011408 injection; HR011408 injection Placebo	-
Arm 3: Medication regimen C-A-B	NovoRapid®; HR011408 injection Placebo	-
Arm 1: Medication regimen A-B-C	HR011408 injection Placebo; HR011408 injection	-
Arm 2: Medication regimen B-C-A	HR011408 injection; HR011408 injection Placebo	-
Arm 1: Medication regimen A-B-C	HR011408 injection; HR011408 injection Placebo	-
Arm 1: Medication regimen A-B-C	NovoRapid®; HR011408 injection Placebo	-
Arm 2: Medication regimen B-C-A	HR011408 injection Placebo; HR011408 injection	-
Arm 2: Medication regimen B-C-A	NovoRapid®; HR011408 injection Placebo	-
Arm 3: Medication regimen C-A-B	HR011408 injection Placebo; HR011408 injection	-

Primary Outcome Measures

Name	Time	Method
Area under the serum concentration-time curve of insulin aspart	From 0 to 30 mins after trial product administration

Secondary Outcome Measures

Name	Time	Method
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
Area under the serum concentration-time curve of insulin aspart	From 0 to 6 hours after trial product administration

Trial Locations

Locations (1)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China