Type 2 DiabetesPhase 1NCT05459285
A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects
A Phase 1 study testing 14028 injection and dulaglutide injection 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 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028… 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?
- 14028 injection and dulaglutide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2022to 8 Jul 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily
- Healthy male subjects aged 18 to 45 (including the critical value)
- Weight > or = 50 kg, and 19.0 kg/m2 < or = BMI (body mass index) < or = 28.0 kg/m2
- Vital signs, physical examination, laboratory examination, electrocardiogram, thyroid color Doppler ultrasound, abdominal color Doppler ultrasound and chest X-ray (anteroposterior) and other test results during screening are normal or have no clinical significance as judged by the investigator
- Subjects agree to use effective contraceptive methods from signing the informed consent form to the end of the trial drug use within 3 months, and there is no sperm donation plan.
Who cannot join
- The investigator judges that the subjects have the following clinically significant diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases)
- Have a medical or family history of medullary thyroid cancer (grandparents, parents, brothers and sisters), or a genetic disease that lead to medullary thyroid cancer; or a history or family history of multiple endocrine neoplasia syndrome type 2
- Past or current history of pancreatitis (chronic or acute pancreatitis)
- Past or current history of habitual constipation or intestinal obstruction
- Clinically significant history of drug allergy or specific allergic disease (asthma, urticaria) or known allergy to the investigational drug and any component or related excipient components
- Those who have difficulty with venous blood collection, a history of needle sickness, haemorrhage, or a known tendency to severe bleeding
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- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIV), and Treponema pallidum antibody (TPAb)
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products (except vitamin supplements) within 2 weeks before the first dose
- Those who have a history of vaccination with live attenuated vaccine within 3 months before screening or a history of vaccination with inactivated vaccine within 1 month before screening
- Those who have previously received dulaglutide or any other glucagon-like peptide-1 (GLP-1) analog
- Those who donated blood or lost blood > or = 400 mL within 3 months before screening, or those who plan to donate blood
- Those who smoked more than 5 cigarettes per day within 3 months before screening or who could not give up smoking during the period from signing the informed consent to the subjects leaving the group
- Those who have a history of alcohol abuse, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) , or those who have a positive alcohol breath test during the screening period
- Those who have a history of drug abuse or poison use within 2 years before screening, or those who have a positive test results for urine drug abuse screening during the screening period
- Participated in other clinical trials within 3 months before screening (subjects who are not randomized or not receiving treatment withdraw from the study before treatment, they can be enrolled in this study)
- Acute illness or concomitant medication occurred from the time of signing the informed consent to the first administration
- Those who have special requirements for diet and cannot obey the unified diet
- Others judged by the investigator to be unsuitable to participate in this trial
- Subjects who may not be able to complete this trial for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ，Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study
To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects
- Conditions
- Type 2 Diabetes
- Being tested
- 14028 injection, dulaglutide injection
- 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.
14028 injectionBiological
14028 injection, single dose, s.c. injection
dulaglutide injectionBiological
Also called TRULICITY®
dulaglutide injection(TRULICITY®), single dose, s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| 14028 injection | Experimental | Subjects receive 14028 injection in the study, 0.75mg, once Receives: Biological: 14028 injection |
| dulaglutide injection (TRULICITY®) | Active comparator | Subjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once Receives: Biological: dulaglutide injection |
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 384 hours after administration
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
Secondary outcomes (6)
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 384 h
Measured: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Time to reach maximum plasma concentration following drug administration (Tmax)
Time to maximum concentration
Measured: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Elimination half-life (t1/2)
Elimination half-life
Measured: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent total body clearance (CL/F)
Apparent total body clearance
Measured: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Measured: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Elimination constants (λz)
Elimination constants
Measured: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start31 May 2022
- Primary completion2 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Hou, doctor, Principal investigator, Peking University Care Luzhong HospitalHong Wang, bachelor, Principal investigator, Peking University Care Luzhong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459285
- Sponsor's protocol ID
- 14028-DM-101
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
IDF (International Diabetes Federation) Diabetes Atlas, ninth edition, 2019.
EMA. Trulicity® Risk Management Plan.2021.01.02.
Geiser JS, Heathman MA, Cui X, Martin J, Loghin C, Chien JY, de la Pena A. Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials. Clin Pharmacokinet. 2016 May;55(5):625-34. doi: 10.1007/s40262-015-0338-3.
PubMed 26507721FDA. Guidance for Industry - Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Dec. 2016.
Barrington P, Chien JY, Tibaldi F, Showalter HD, Schneck K, Ellis B. LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Diabetes Obes Metab. 2011 May;13(5):434-8. doi: 10.1111/j.1463-1326.2011.01365.x. Epub 2011 Jan 19.
PubMed 21251179Barrington P, Chien JY, Showalter HD, Schneck K, Cui S, Tibaldi F, Ellis B, Hardy TA. A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab. 2011 May;13(5):426-33. doi: 10.1111/j.1463-1326.2011.01364.x. Epub 2011 Jan 19.
PubMed 21251178de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7.
PubMed 28357715FDA (Food Drug Administration), Clinical Pharmacology Biopharmaceutics Review(s), 2014.
EMA (European Medicines Agency), Public assessment report.2014
Gao X, Di Y, Lv Y, Luan Y, Xiong Y, Xu Y, Li Y, Guo L, Li X, Deng L, Zhuang Y, Hou J. A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity(R)) in healthy Chinese subjects. Clin Transl Sci. 2024 Apr;17(4):e13775. doi: 10.1111/cts.13775.
PubMed 38651744
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ，Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05459285
- Acronym / sponsor ID
- 14028-DM-101
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 2 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 14 Jul 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 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14028 injection | Experimental | Biological: 14028 injectionSubjects receive 14028 injection in the study, 0.75mg, once |
| dulaglutide injection (TRULICITY®) | Active comparator | Biological: dulaglutide injectionSubjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily
- Healthy male subjects aged 18 to 45 (including the critical value)
- Weight > or = 50 kg, and 19.0 kg/m2 < or = BMI (body mass index) < or = 28.0 kg/m2
- Vital signs, physical examination, laboratory examination, electrocardiogram, thyroid color Doppler ultrasound, abdominal color Doppler ultrasound and chest X-ray (anteroposterior) and other test results during screening are normal or have no clinical significance as judged by the investigator
- Subjects agree to use effective contraceptive methods from signing the informed consent form to the end of the trial drug use within 3 months, and there is no sperm donation plan.
Key exclusion criteria (19 listed)
- The investigator judges that the subjects have the following clinically significant diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases)
- Have a medical or family history of medullary thyroid cancer (grandparents, parents, brothers and sisters), or a genetic disease that lead to medullary thyroid cancer; or a history or family history of multiple endocrine neoplasia syndrome type 2
- Past or current history of pancreatitis (chronic or acute pancreatitis)
- Past or current history of habitual constipation or intestinal obstruction
- Clinically significant history of drug allergy or specific allergic disease (asthma, urticaria) or known allergy to the investigational drug and any component or related excipient components
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 |
|---|---|---|
| 14028 injection14028 injection, single dose, s.c. injection | Biological | 14028 injection |
| dulaglutide injectionAlso: TRULICITY®dulaglutide injection(TRULICITY®), single dose, s.c. injection | Biological | dulaglutide injection (TRULICITY®) |
Primary outcome
Maximum (peak) plasma drug concentration(Cmax)
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Maximum (peak) plasma drug concentration
Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)
Time frame: 0 hour (pre-dose, within 30mins) to infinity
The area under the plasma concentration curve from 0 to ∞
6 secondary outcomes
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Time to reach maximum plasma concentration following drug administration (Tmax)
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Elimination half-life (t1/2)
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent total body clearance (CL/F)
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent volume of distribution (Vd/F)
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Elimination constants (λz)
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after 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 25 Aug 2022.
- BackgroundIDF (International Diabetes Federation) Diabetes Atlas, ninth edition, 2019.
- BackgroundEMA. Trulicity® Risk Management Plan.2021.01.02.
- Background: PubMed 26507721Geiser JS, Heathman MA, Cui X, Martin J, Loghin C, Chien JY, de la Pena A. Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials. Clin Pharmacokinet. 2016 May;55(5):625-34. doi: 10.1007/s40262-015-0338-3.
- BackgroundFDA. Guidance for Industry - Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Dec. 2016.
- Background: PubMed 21251179Barrington P, Chien JY, Tibaldi F, Showalter HD, Schneck K, Ellis B. LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Diabetes Obes Metab. 2011 May;13(5):434-8. doi: 10.1111/j.1463-1326.2011.01365.x. Epub 2011 Jan 19.
- Background: PubMed 21251178Barrington P, Chien JY, Showalter HD, Schneck K, Cui S, Tibaldi F, Ellis B, Hardy TA. A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab. 2011 May;13(5):426-33. doi: 10.1111/j.1463-1326.2011.01364.x. Epub 2011 Jan 19.
- Background: PubMed 28357715de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7.
- BackgroundFDA (Food Drug Administration), Clinical Pharmacology Biopharmaceutics Review(s), 2014.
- BackgroundEMA (European Medicines Agency), Public assessment report.2014
- Derived from this study: PubMed 38651744Gao X, Di Y, Lv Y, Luan Y, Xiong Y, Xu Y, Li Y, Guo L, Li X, Deng L, Zhuang Y, Hou J. A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity(R)) in healthy Chinese subjects. Clin Transl Sci. 2024 Apr;17(4):e13775. doi: 10.1111/cts.13775.
- Individual participant dataSharing planned: No
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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.
Jie Hou, doctor principal investigator
Peking University Care Luzhong Hospital
Hong Wang, bachelor principal investigator
Peking University Care Luzhong Hospital
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 14028 injection and dulaglutide injection 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 19 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 25 Aug 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 384 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 NCT05459285, which also lists 10 linked publications.
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 25 Aug 2022.