Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

Diabetes Clinical Trial

Official title:

Comparing Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Subjects With Diabetics- A Randomized, Double-Blind, Three-cycle Crossover Phase I Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375031
• Other study ID #: HR011408-103
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: April 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Hong Chen
• Phone: +86-0518-82342973
• Email: hong.chen[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 15, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• HR011408 injection; HR011408 injection Placebo
Medication regimen-A: HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum
• NovoRapid®; HR011408 injection Placebo
Medication regimen-B: NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum
• HR011408 injection Placebo; HR011408 injection
Medication regimen-C: HR011408 injection Placebo, ante cibum: HR011408 injection, post cibum

Locations

Country	Name	City	State
China	The Second Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum concentration-time curve of insulin aspart		From 0 to 30 mins after trial product administration
Secondary	Area under the serum concentration-time curve of insulin aspart		From 0 to 6 hours after trial product administration
Secondary	Plasma glucose concentration		From 0 to 6 hours after start of a standardised meal
Secondary	Number of subjects with adverse events and severity of adverse events		From first dose to the last visit, approximately 2 months