Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

NCT06375031 | Recruiting Phase 1

• 1 other identifier: HR011408-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Area under the serum concentration-time curve of insulin aspart

  From 0 to 30 mins after trial product administration

Secondary Outcomes (3)

• Area under the serum concentration-time curve of insulin aspart

  From 0 to 6 hours after trial product administration

• 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

Study Arms (3)

Arm 1: Medication regimen A-B-C

EXPERIMENTAL

Drug: HR011408 injection; HR011408 injection Placebo; Drug: NovoRapid®; HR011408 injection Placebo; Drug: HR011408 injection Placebo; HR011408 injection

Arm 2: Medication regimen B-C-A

EXPERIMENTAL

Drug: HR011408 injection; HR011408 injection Placebo; Drug: NovoRapid®; HR011408 injection Placebo; Drug: HR011408 injection Placebo; HR011408 injection

Arm 3: Medication regimen C-A-B

EXPERIMENTAL

Drug: HR011408 injection; HR011408 injection Placebo; Drug: NovoRapid®; HR011408 injection Placebo; Drug: HR011408 injection Placebo; HR011408 injection

Interventions

HR011408 injection; HR011408 injection Placebo DRUG

Medication regimen-A: HR011408 injection, ante cibum; HR011408 injection Placebo , post cibum

Arm 1: Medication regimen A-B-C; Arm 2: Medication regimen B-C-A; Arm 3: Medication regimen C-A-B

NovoRapid®; HR011408 injection Placebo DRUG

Medication regimen-B: NovoRapid®, ante cibum; HR011408 injection Placebo, post cibum

Arm 1: Medication regimen A-B-C; Arm 2: Medication regimen B-C-A; Arm 3: Medication regimen C-A-B

HR011408 injection Placebo; HR011408 injection DRUG

Medication regimen-C: HR011408 injection Placebo, ante cibum: HR011408 injection, post cibum

Arm 1: Medication regimen A-B-C; Arm 2: Medication regimen B-C-A; Arm 3: Medication regimen C-A-B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Subjects had to meet all the following criteria to enrol this study
• Male or female aged 18-64 years (both inclusive)；
• Body mass index 18.5-35.0 kg/m2 (both inclusive)；
• Diagnosed with type 1 diabetes or type 2 diabetes≥ 12 months at screening；
• HbA1c ≤9.0% by local laboratory at screening；
• 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；
• 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.

You may not qualify if:

• \- Subjects who meet any of the following criteria will be excluded from this study.
• \. The following laboratory or ancillary abnormalities were present from screening until randomization:
• \) Poor blood pressure control, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
• \. Subject has any history or evidence meet the following diseases or conditions:
• have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator.
• Have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening;
• Proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
• \. Previous and anticipated concomitant treatments:
• 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
• 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.
• \. General information:
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent nicotine per day).
• Previous participation in this study. Participation was defined as randomised.
• \. Any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Hong Chen

CONTACT

+86-0518-82342973; hong.chen@hengrui.com

Yifan Li

CONTACT

+86-0518-82342973; yifan.li@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 15, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)