Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-07-15

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1: Medication regimen A-B-C

Group Type EXPERIMENTAL

HR011408 injection; HR011408 injection Placebo

Intervention Type DRUG

Medication regimen-A:

HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum

NovoRapid®; HR011408 injection Placebo

Intervention Type DRUG

Medication regimen-B:

NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum

HR011408 injection Placebo; HR011408 injection

Intervention Type DRUG

Medication regimen-C:

HR011408 injection Placebo, ante cibum:

HR011408 injection, post cibum

Arm 2: Medication regimen B-C-A

Group Type EXPERIMENTAL

HR011408 injection; HR011408 injection Placebo

Intervention Type DRUG

Medication regimen-A:

HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum

NovoRapid®; HR011408 injection Placebo

Intervention Type DRUG

Medication regimen-B:

NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum

HR011408 injection Placebo; HR011408 injection

Intervention Type DRUG

Medication regimen-C:

HR011408 injection Placebo, ante cibum:

HR011408 injection, post cibum

Arm 3: Medication regimen C-A-B

Group Type EXPERIMENTAL

HR011408 injection; HR011408 injection Placebo

Intervention Type DRUG

Medication regimen-A:

HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum

NovoRapid®; HR011408 injection Placebo

Intervention Type DRUG

Medication regimen-B:

NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum

HR011408 injection Placebo; HR011408 injection

Intervention Type DRUG

Medication regimen-C:

HR011408 injection Placebo, ante cibum:

HR011408 injection, post cibum

Interventions

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HR011408 injection; HR011408 injection Placebo

Medication regimen-A:

HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum

Intervention Type DRUG

NovoRapid®; HR011408 injection Placebo

Medication regimen-B:

NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum

Intervention Type DRUG

HR011408 injection Placebo; HR011408 injection

Medication regimen-C:

HR011408 injection Placebo, ante cibum:

HR011408 injection, post cibum

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No