Clinical trial NCT06375031: Comparison of HR011408 and NovoRapid® in Subjects With Diabetics
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the serum concentration-time curve of insulin aspart
timeFrame: From 0 to 30 mins after trial product administration
Secondary outcomes:
measure: Area under the serum concentration-time curve of insulin aspart
timeFrame: From 0 to 6 hours after trial product administration
measure: Plasma glucose concentration
timeFrame: From 0 to 6 hours after start of a standardised meal
measure: Number of subjects with adverse events and severity of adverse events
timeFrame: From first dose to the last visit, approximately 2 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
References: