Comparing two diabetes medications in adults

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

This study tests how well two diabetes medications, HR011408 and NovoRapid®, work for adults with diabetes to see which one helps control blood sugar better.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06375031 on ClinicalTrials.gov

What this trial studies

This study aims to compare the pharmacokinetics and pharmacodynamics of HR011408 and NovoRapid® in adults diagnosed with diabetes. Participants will receive either HR011408, NovoRapid®, or a placebo in various combinations to assess the effectiveness and safety of these treatments. The study will involve individuals aged 18 to 64 who have been managing their diabetes for at least 12 months. The goal is to determine how these medications perform in controlling blood sugar levels and their overall impact on diabetes management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-64 with type 1 or type 2 diabetes who have been on insulin therapy for at least 8 weeks.

Not a fit: Patients with poorly controlled blood pressure or significant laboratory abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for diabetes patients, enhancing their blood sugar control.

How similar studies have performed: While this study is exploring a specific comparison, similar studies have shown promise in evaluating new diabetes treatments, indicating potential for success.

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.

Where this trial is running

Hefei, Anhui

• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Hong Chen

Conditions: Diabetes