Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

May 20, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Medication regimen A-B-C
Drug: HR011408 injection; HR011408 injection Placebo

Medication regimen-A:

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

Drug: NovoRapid®; HR011408 injection Placebo

Medication regimen-B:

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

Drug: HR011408 injection Placebo; HR011408 injection

Medication regimen-C:

HR011408 injection Placebo, ante cibum:

HR011408 injection, post cibum
Experimental: Arm 2: Medication regimen B-C-A
Drug: HR011408 injection; HR011408 injection Placebo

Medication regimen-A:

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

Drug: NovoRapid®; HR011408 injection Placebo

Medication regimen-B:

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

Drug: HR011408 injection Placebo; HR011408 injection

Medication regimen-C:

HR011408 injection Placebo, ante cibum:

HR011408 injection, post cibum
Experimental: Arm 3: Medication regimen C-A-B
Drug: HR011408 injection; HR011408 injection Placebo

Medication regimen-A:

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

Drug: NovoRapid®; HR011408 injection Placebo

Medication regimen-B:

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

Drug: HR011408 injection Placebo; HR011408 injection

Medication regimen-C:

HR011408 injection Placebo, ante cibum:

HR011408 injection, post cibum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the serum concentration-time curve of insulin aspart
Time Frame: From 0 to 30 mins after trial product administration
From 0 to 30 mins after trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum concentration-time curve of insulin aspart
Time Frame: From 0 to 6 hours after trial product administration
From 0 to 6 hours after trial product administration
Plasma glucose concentration
Time Frame: From 0 to 6 hours after start of a standardised meal
From 0 to 6 hours after start of a standardised meal
Number of subjects with adverse events and severity of adverse events
Time Frame: From first dose to the last visit, approximately 2 months
From first dose to the last visit, approximately 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR011408-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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