Type 2 DiabetesPhase 1NCT05294536
A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects
A Phase 1 study testing Liraglutide injection,RD12014 and Liraglutide injection,Victoza in people with Type 2 Diabetes, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Liraglutide injection,RD12014 and Liraglutide injection,Victoza
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2020to 27 Nov 2020
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol;
- 2. Aged between 18 and 45 years old of healthy male subjects ;
- 3. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
- 4. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
- 5. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance;
Who cannot join
- 1. Have a history of fainting needles, fainting blood;
- 2. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
- 3. Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug;
- 4. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
- 5. Those who have been screened positive for drugs at screening;
- 6. Donated blood (> 400 ml) within 3 months before taking the study drug;
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- 7. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug.
- 8. Alcohol abuse (drinking 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 positive for breath alcohol test ;
- 9. Those who have been screened positive for drugs or have a history of drug abuse;
- 10. Known allergy to Liraglutide or any of the excipients of the formulation;
- 11. Those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;Or have a history or family history of multiple endocrine adenomatosis;
- 12. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug;
- 13. During the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods
- 14. Other cases judged by researchers to be unsuitable for selection.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers
To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- Liraglutide injection,RD12014, Liraglutide injection,Victoza
- 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.
Liraglutide injection,RD12014Drug
single dose, s.c. injection
Liraglutide injection,VictozaDrug
single dose, s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide injection (RD12014)+ Victoza | Experimental | Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle. Receives: Drug: Liraglutide injection,RD12014; Drug: Liraglutide injection,Victoza |
| Victoza + Liraglutide injection (RD12014) | Experimental | Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle. Receives: Drug: Liraglutide injection,RD12014; Drug: Liraglutide injection,Victoza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum (peak) plasma drug concentration(Cmax)
Maximum (peak) plasma drug concentration
Measured: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
The area under the plasma concentration curve from 0 to 72 h
Measured: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Secondary outcomes (6)
Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)
The area under the plasma concentration curve from 0 to ∞
Measured: 0 hour（pre-dose,within 30mins） to infinity after administration
Time to reach maximum plasma concentration following drug administration (Tmax)
Time to maximum concentration
Measured: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Elimination half-life (t1/2)
Elimination half-life
Measured: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Apparent total body clearance (CL/F)
Apparent total body clearance
Measured: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Measured: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Adverse Event, Serious Adverse Event
Monitor the safety indicators of subjects during the trial
Measured: Up to day 4 after the second dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start22 Jun 2020
- Primary completion20 Jul 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294536
- Sponsor's protocol ID
- 12014-P-01/CRC-C1944
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou R, Guo L, Gao X, Wang Y, Xu W, Zou Y, Li W, Zhuang Y, Liu G, Liu Y. A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects. Clin Transl Sci. 2022 Oct;15(10):2458-2467. doi: 10.1111/cts.13374. Epub 2022 Jul 31.
PubMed 35871497
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05294536
- Acronym / sponsor ID
- 12014-P-01/CRC-C1944
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide injection (RD12014)+ Victoza | Experimental | Drug: Liraglutide injection,RD12014, Drug: Liraglutide injection,VictozaSubjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle. |
| Victoza + Liraglutide injection (RD12014) | Experimental | Drug: Liraglutide injection,RD12014, Drug: Liraglutide injection,VictozaSubjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol;
- 2. Aged between 18 and 45 years old of healthy male subjects ;
- 3. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
- 4. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
- 5. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance;
Key exclusion criteria (14 listed)
- 1. Have a history of fainting needles, fainting blood;
- 2. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
- 3. Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug;
- 4. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
- 5. Those who have been screened positive for drugs at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide injection,RD12014single dose, s.c. injection | Drug | Liraglutide injection (RD12014)+ Victoza, Victoza + Liraglutide injection (RD12014) |
| Liraglutide injection,Victozasingle dose, s.c. injection | Drug | Liraglutide injection (RD12014)+ Victoza, Victoza + Liraglutide injection (RD12014) |
Primary outcome
Maximum (peak) plasma drug concentration(Cmax)
Time frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Maximum (peak) plasma drug concentration
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
The area under the plasma concentration curve from 0 to 72 h
6 secondary outcomes
Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)
Time frame: 0 hour（pre-dose,within 30mins） to infinity after administration
Time to reach maximum plasma concentration following drug administration (Tmax)
Time frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Elimination half-life (t1/2)
Time frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Apparent total body clearance (CL/F)
Time frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Apparent volume of distribution (Vd/F)
Time frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Adverse Event, Serious Adverse Event
Time frame: Up to day 4 after the second dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Derived from this study: PubMed 35871497Zhou R, Guo L, Gao X, Wang Y, Xu W, Zou Y, Li W, Zhuang Y, Liu G, Liu Y. A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects. Clin Transl Sci. 2022 Oct;15(10):2458-2467. doi: 10.1111/cts.13374. Epub 2022 Jul 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liraglutide injection,RD12014 and Liraglutide injection,Victoza 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 5 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 24 Mar 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?
Maximum (peak) plasma drug concentration(Cmax) (time frame: 0 hour（pre-dose,within 30mins） to 72 hours after administration). 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 NCT05294536, which also lists 1 linked publication.
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 24 Mar 2022.