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Type 2 DiabetesPhase 1NCT05576298

A Clinical Study Comparing the Pharmacokinetics and Pharmacodynamic Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection (Tresiba®) in Healthy Subjects

A Phase 1 study testing Insulin degludec injection, RD15003 and Insulin degludec, Tresiba in people with Type 2 Diabetes, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®) listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided by Dongguan Dongyang Sunshine Biopharmaceutical R\&D Co., Ltd. Read more about this study

Who is it for?
Ages 18 months to 45 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
Insulin degludec injection, RD15003 and Insulin degludec, Tresiba
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
8 Oct 2021to 21 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Volunteer to participate in the trial, and sign the informed consent form, and be able to complete the trial in accordance with the requirements of the plan;
  • When signing the informed consent form, healthy subjects aged 18-45 (including the cut-off value) are not limited to males and females;
  • At the time of screening, male weight > or = 50 kg, female weight > or = 45 kg, body mass index (BMI) > or = 19.0 and < or = 26.0 kg/m2;
  • After medical history inquiry, there is no clinically significant heart, liver, kidney, digestive tract, nervous system disease, and metabolic abnormality history;
  • Vital signs, physical examination, laboratory examination and/or ECG, chest X-ray examination results are normal or abnormal, but the investigator judges that they have no clinical significance;
  • Normal glucose tolerance [fasting blood glucose (FPG) <6.1 mmol/L, and oral glucose tolerance test (OGTT) 2 h postprandial blood glucose <7.8 mmol/L];
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  • Insulin release test (IRT) results are normal or abnormal, but the investigator judges that it has no clinical significance;
  • Have good venous conditions, so that blood collection channels can be established according to the research plan;
  • There was no birth plan during the study period and promised to use reliable contraceptive measures throughout the study period until 4 weeks after the last administration of the trial drug.

Who cannot join

  • Have a history of hypoglycemia within 3 months before screening;
  • Those who have taken any prescription drugs, Chinese herbal medicines, over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol), and health care products (except routine supplementary vitamins and calcium) within 4 weeks before administration;
  • During screening, the test results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or Treponema pallidum antibody were positive;
  • Have a history of malignant tumors before screening;
  • Participated in any drug or device clinical research within 3 months before screening (the definition of participation: refers to random or receiving experimental drugs or devices);
  • Blood donation > or = 400 mL within 3 months before administration, or blood loss > or = 400 mL due to any reason;
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  • People who are known to be allergic to the test drug or its excipients;
  • People who drink regularly within 3 months before administration, that is, drink more than 21 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcoholic spirits or 150 mL of wine), or those who have a positive alcohol breath test ;
  • Those who have a positive urine drug screening;
  • Positive anti-insulin antibody during the screening period;
  • Female subjects who are breastfeeding, or women who have a positive blood pregnancy test during the screening period;
  • Those who smoked more than 10 cigarettes per day within 3 months before the administration, or failed to comply with the ban on smoking during the trial period;
  • There are any factors considered by the researcher to be unsuitable for participating in the research;
  • If during the period of new coronary pneumonia, the investigator decided to conduct relevant tests for the new coronavirus according to the requirements of the Sichuan Provincial Health Commission and West China Hospital of Sichuan University at the time of the trial, and the abnormal results have clinical significance.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

Other trials in China

About this study

Official title: Pharmacokinetics, Pharmacodynamic, Safety and Immunogenicity Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection ( Tresiba®）in Healthy Subjects: a Phase I Single-center, Randomized, Open-label, Single-dose, Cross-over Clinical Study

To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®) listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided by Dongguan Dongyang Sunshine Biopharmaceutical R\&D Co., Ltd. (RD15003) pharmacokinetics and pharmacodynamic characteristics in healthy subjects, and then to evaluate the bioequivalence of test drugs and control drugs.

Conditions
Type 2 Diabetes
Being tested
Insulin degludec injection, RD15003, Insulin degludec, Tresiba
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin degludec injection, RD15003Biological

    single dose, s.c. injection

  • Insulin degludec, TresibaBiological

    single dose, s.c. injection

Study groups in NCT05576298
Study groupRoleWhat they receive
TR sequenceExperimentalExperimental:Insulin degludec injection (RD15003)+Tresiba Subjects receive Insulin degludec injection(RD15003) in the first cycle and Tresiba in the second cycle.
Receives: Biological: Insulin degludec injection, RD15003; Biological: Insulin degludec, Tresiba
RT sequenceExperimentalExperimental:Tresiba+Insulin degludec injection (RD15003) Subjects receive Insulin Tresiba in the first cycle and degludec injection(RD15003) in the second cycle.
Receives: Biological: Insulin degludec injection, RD15003; Biological: Insulin degludec, Tresiba

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the plasma concentration-time curve from time zero to 24 hours

    AUC0-24h

    Measured: 24 hours after injection

  2. Area under the glucose infusion rate curve from administration to end of clamp from time zero to 24 hours

    GIR-AUC0-24h

    Measured: 24 hours after injection

Secondary outcomes (7)

  1. Area under the plasma concentration-time curve from time zero to 12 hours

    AUC0-12h

    Measured: 12 hours after injection

  2. Area under the glucose infusion rate curve from administration to end of clamp from time zero to 12 hours

    AUCGIR0-12h

    Measured: 12 hours after injection

  3. Safety evaluation

    Incidence of adverse events

    Measured: Up to 24 weeks

  4. Area under the plasma concentration-time curve from time 12 hours to 24 hours

    AUC12-24h

    Measured: 12-24 hours after injection

  5. Area under the plasma concentration-time curve from time zero to t

    AUC0-t

    Measured: 120 hours after injection

  6. Area under the glucose infusion rate curve from administration to end of clamp from time 12 hours to 24 hours

    AUCGIR, 12-24h

    Measured: 12-24 hours after injection

  7. Maximum glucose infusion rate

    GIRmax

    Measured: 24 hours after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start8 Oct 2021
  3. Primary completion21 Mar 2022
  4. Study completion21 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05576298
Sponsor's protocol ID
RD15003-P-01
Status last verified
Sep 2022
First submitted
14 Sep 2022
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Insulin degludec injection, RD15003 and Insulin degludec, Tresiba in people with Type 2 Diabetes, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the plasma concentration-time curve from time zero to 24 hours (time frame: 24 hours after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05576298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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