Type 2 DiabetesPhase 1NCT05029076
Human Bioequivalence Test of Liraglutide Injection
A Phase 1 study testing Liraglutide injection and Victoza in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Liraglutide injection and Victoza
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2019to 1 Jul 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions;
- Able to complete the study according to the requirements of protocol;
- Aged between 18 and 60 years old, both men and women;
- Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value);
- No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
- Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
- The female blood pregnancy test is not pregnant, and the subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before administration to at least 3 months after the last use of the study drug. See the appendix for specific contraceptive measures.
Who cannot join
- Previous disease of the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator determines may affect drug metabolism or safety;
- Have a history of fainting needles, fainting blood;
- Known allergy to Liraglutide and its metabolites or any of the excipients of the formulation;
- Those who smoked more than 5 cigarettes per day during the 3 months before the trial.
- History of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine);
- Donated blood or lost a lot of blood (> 450 ml) within 2 months before taking the study drug ;
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- Have taken any drug that changes liver enzyme activity 28 days before taking the study drug (such as liver drug enzyme inhibitor chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver drug enzyme inducer barbital Drugs, carbamazepine, rifampicin, dexamethasone, etc.);
- Have taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug;
- During the trial it is necessary to use tobacco, alcohol, and caffeine-containing drinks, or certain foods that may affect metabolism (such as grapefruit, grapefruit juice, etc.), or major changes in diet or exercise habits before the test, or other effects that affect drug absorption, Factors such as distribution, metabolism, excretion, etc;
- Have taken the study drug or participated in the drug clinical trial within 2 months before taking the study drug;
- Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
- Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or during the test;
- Those who have been screened positive for drugs or have a history of drug abuse in the past five years or have used drugs in the 3 months before the trial;
- Blood collection is difficult or cannot tolerate venipuncture blood collection;
- Acute illness during the screening phase or before study medication;
- The subject is unable or can not comply with ward management regulations;
- The subject is unable to complete the study due to personal reasons;
- Other cases judged by researchers to be unsuitable for selection.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130021
About this study
To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation Victoza ® in healthy subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- 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 injectionDrug
Human glucagon-like peptides-1 analogue
VictozaDrug
Human glucagon-like peptides-1 analogue
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide injection + Victoza | Experimental | Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle. Receives: Drug: Liraglutide injection; Drug: Victoza |
| Victoza +Liraglutide injection | Experimental | Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle. Receives: Drug: Liraglutide injection; Drug: 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 60mins） to 72hours after administration on day1 and day 15.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Time to maximum concentration
Measured: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.
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 infinity
Measured: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Terminal disposition rate constant/terminal rate constant (λz)
Apparent end elimination rate constant
Measured: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Elimination half-life (t1/2)
The time required for the highest concentration of the drug in plasma to decrease by half
Measured: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Apparent total body clearance
Measured: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent volume of distribution after non-intravenous administration (Vd/F)
Apparent volume of distribution
Measured: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Bioavailability (systemic availability of the administered dose)
Relative bioavailability
Measured: 0 hour（pre-dose, within 60mins） to 72 hours after administration on day1 and day 15.
Adverse Event, Serious Adverse Event and Drug Combination
Monitor the safety indicators of subjects during the trial
Measured: up to day 15
Secondary outcomes (6)
body temperature
abnormal body temperature
Measured: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
pulse
abnormal pulse
Measured: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
blood pressure
abnormal blood pressure
Measured: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
clinical symptoms
Any discomfort spontaneously reported by the subject
Measured: From the screening period to day 18 after the first administration
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Monitor the safety indicators of subjects during the trial，For example: skin, mucous membrane, head (head, eyes, ears, nose, mouth), neck, chest (chest, breast, lung, heart), abdomen (liver, gallbladder, spleen, kidney, bladder), spine, limbs, nervous system, lymph nodes, etc，and calculate the Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From the screening period to day 18 after the first administration
The Number of participants with abnormal laboratory examinations
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
Measured: From the screening period to day 18 after the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start21 May 2019
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
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 Chia Tai Tianqing Pharmaceutical Group 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029076
- Sponsor's protocol ID
- ZDTQ-BE-2019-LLLT
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu Z, Liu Z, Wang Y, Xue J, Chang T, Cui Y, Cheng Y, Liu G, Wang W, Zhou Y, Yu S, Ren Q, Yang W, Qu X, Chen J, Chen X, Deng Q, Yang H, Wang X. Comparing the bioequivalence and safety of liraglutide in healthy Chinese subjects: an open, single-dose, randomized, repeated, two-sequence, two-cycle phase I clinical trial. Expert Rev Clin Pharmacol. 2023 Apr;16(4):363-370. doi: 10.1080/17512433.2023.2188192. Epub 2023 Mar 8.
PubMed 36883362
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Bioequivalence Test of Liraglutide Injection
- ClinicalTrials.gov ID
- NCT05029076
- Acronym / sponsor ID
- ZDTQ-BE-2019-LLLT
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 31 Aug 2021 (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 bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation 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 + Victoza | Experimental | Drug: Liraglutide injection, Drug: VictozaSubjects receive liraglutide injection in the first cycle and Victoza in the second cycle. |
| Victoza +Liraglutide injection | Experimental | Drug: Liraglutide injection, Drug: VictozaSubjects receive Victoza in the first cycle and liraglutide injection in the second cycle. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions;
- Able to complete the study according to the requirements of protocol;
- Aged between 18 and 60 years old, both men and women;
- Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value);
- No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
Key exclusion criteria (18 listed)
- Previous disease of the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator determines may affect drug metabolism or safety;
- Have a history of fainting needles, fainting blood;
- Known allergy to Liraglutide and its metabolites or any of the excipients of the formulation;
- Those who smoked more than 5 cigarettes per day during the 3 months before the trial.
- History of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine);
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 injectionHuman glucagon-like peptides-1 analogue | Drug | Liraglutide injection + Victoza, Victoza +Liraglutide injection |
| VictozaHuman glucagon-like peptides-1 analogue | Drug | Liraglutide injection + Victoza, Victoza +Liraglutide injection |
Primary outcome
Maximum (peak) plasma drug concentration(Cmax)
Time frame: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.
Maximum (peak) plasma drug concentration
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Time frame: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.
Time to maximum concentration
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
The area under the plasma concentration curve from 0 to infinity
Terminal disposition rate constant/terminal rate constant (λz)
Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent end elimination rate constant
Elimination half-life (t1/2)
Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
The time required for the highest concentration of the drug in plasma to decrease by half
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent total body clearance
Apparent volume of distribution after non-intravenous administration (Vd/F)
Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent volume of distribution
Bioavailability (systemic availability of the administered dose)
Time frame: 0 hour（pre-dose, within 60mins） to 72 hours after administration on day1 and day 15.
Relative bioavailability
Adverse Event, Serious Adverse Event and Drug Combination
Time frame: up to day 15
Monitor the safety indicators of subjects during the trial
6 secondary outcomes
body temperature
Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
pulse
Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
blood pressure
Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
clinical symptoms
Time frame: From the screening period to day 18 after the first administration
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Time frame: From the screening period to day 18 after the first administration
The Number of participants with abnormal laboratory examinations
Time frame: From the screening period to day 18 after the first administration
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 31 Aug 2021.
- Derived from this study: PubMed 36883362Xu Z, Liu Z, Wang Y, Xue J, Chang T, Cui Y, Cheng Y, Liu G, Wang W, Zhou Y, Yu S, Ren Q, Yang W, Qu X, Chen J, Chen X, Deng Q, Yang H, Wang X. Comparing the bioequivalence and safety of liraglutide in healthy Chinese subjects: an open, single-dose, randomized, repeated, two-sequence, two-cycle phase I clinical trial. Expert Rev Clin Pharmacol. 2023 Apr;16(4):363-370. doi: 10.1080/17512433.2023.2188192. Epub 2023 Mar 8.
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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 and Victoza in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group 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 7 inclusion and 18 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 31 Aug 2021. 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 60mins） to 72hours after administration on day1 and day 15.). The study lists 9 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 NCT05029076, 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 31 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.