Type 2 Diabetes MellitusPhase 1NCT03565458
Gemigliptin, Dapagliflozin, Empagliflozin DDI Study
A Phase 1 study testing Gemigliptin, Dapagliflozin and Empagliflozin in people with Type 2 Diabetes Mellitus, run by LG Chem at 1 site in South Korea.
Trial summary
gemigliptin,SGLT-2i DDI study Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Gemigliptin, Dapagliflozin and Empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2018to 22 Dec 2018
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults at age between 19 to 55 at the time of the screening
- Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
- Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
- subjects who is consented in writing to be sure to comply with the requirements of the clinical trial
Who cannot join
- Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
- Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
- Subject who had infection disease or serious injury within 21 days before the randomization
- Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
- Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
Show all 19Show fewer
- Those who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the clinical trial drug within 30 days of randomization
- Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
- subject who drinks the average amount per week exceeding 140 g of alcohol
- Subject whose daily average smoking amount exceeds 20 pieces per day
- Average daily grapefruit juice intake exceeding 2 cups
- Subject who had a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 70 mmHg, or greater than 100 mmHg at the time of screening test
- Subject with a glomerular filtration rate of less than 60 mL / min / 1.73m^2 calculated from serum creatinine values at the time of screening
- Subject whose blood creatinine, AST, ALT or γ-GT levels exceeded the upper limit of the reference range by 1.5 times the screening test
- Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test
- Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history
- Subject who have clinically significant abnormalities in other clinical tests
- Subject with clinically significant abnormal ECG findings
- Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Gemigliptin and Dapagliflozin or Empagliflozin in Healthy Adult Volunteers
gemigliptin,SGLT-2i DDI study
Read the detailed description
LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin \& dapagliflozin and gemigliptin \& empagliflozin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Gemigliptin, Dapagliflozin, Empagliflozin
- 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.
GemigliptinDrug
Also called zemiglo
zemiglo 50mg,LG Chem
DapagliflozinDrug
Also called forxiga
forxiga, dapagliflozin 10mg
EmpagliflozinDrug
Also called jardiance
jardiance 25mg, empagliflozin
| Study group | Role | What they receive |
|---|---|---|
| gemigliptin | Experimental | gemigliptin single dose Receives: Drug: Gemigliptin |
| dapagliflozin | Experimental | dapagliflozin single dose Receives: Drug: Dapagliflozin |
| gemigliptin and dapagliflozin | Experimental | co-administration of gemigliptin and dapagliflozin Receives: Drug: Gemigliptin; Drug: Dapagliflozin |
| empagliflozin | Experimental | empagliflozin single dose Receives: Drug: Empagliflozin |
| gemigliptin and empagliflozin | Experimental | co-administration of gemigliptin and empagliflozin Receives: Drug: Gemigliptin; Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin
AUCτ
Measured: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin
Css,max
Measured: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary outcomes (6)
tss,max of gemigliptin, dapagliflozin, empagliflozin
tss,max
Measured: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin
Css,min
Measured: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite
AUCτ
Measured: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax)of gemigliptin metabolite
Css,max
Measured: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration(Css,min) of gemigliptin metabolite
Css,min
Measured: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
metabolic ratio of gemigliptin
metabolic ratio
Measured: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start5 Apr 2018
- Primary completion20 Aug 2018 (estimated)
- Study completion22 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jungryul kim, doctor, Principal investigator, samsung seoul medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565458
- Sponsor's protocol ID
- LG-DPCL018
- Status last verified
- May 2018
- First submitted
- 24 May 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Gemigliptin and Dapagliflozin or Empagliflozin in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03565458
- Acronym / sponsor ID
- LG-DPCL018
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 20 Aug 2018 (estimated)
- Study completion
- 22 Dec 2018 (estimated)
- First posted
- 21 Jun 2018 (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.
gemigliptin,SGLT-2i DDI study
Detailed description
LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin \& dapagliflozin and gemigliptin \& empagliflozin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| gemigliptin | Experimental | Drug: Gemigliptingemigliptin single dose |
| dapagliflozin | Experimental | Drug: Dapagliflozindapagliflozin single dose |
| gemigliptin and dapagliflozin | Experimental | Drug: Gemigliptin, Drug: Dapagliflozinco-administration of gemigliptin and dapagliflozin |
| empagliflozin | Experimental | Drug: Empagliflozinempagliflozin single dose |
| gemigliptin and empagliflozin | Experimental | Drug: Gemigliptin, Drug: Empagliflozinco-administration of gemigliptin and empagliflozin |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male adults at age between 19 to 55 at the time of the screening
- Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
- Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
- subjects who is consented in writing to be sure to comply with the requirements of the clinical trial
Key exclusion criteria (19 listed)
- Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
- Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
- Subject who had infection disease or serious injury within 21 days before the randomization
- Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
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 |
|---|---|---|
| GemigliptinAlso: zemiglozemiglo 50mg,LG Chem | Drug | gemigliptin, gemigliptin and dapagliflozin, gemigliptin and empagliflozin |
| DapagliflozinAlso: forxigaforxiga, dapagliflozin 10mg | Drug | dapagliflozin, gemigliptin and dapagliflozin |
| EmpagliflozinAlso: jardiancejardiance 25mg, empagliflozin | Drug | empagliflozin, gemigliptin and empagliflozin |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
AUCτ
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Css,max
6 secondary outcomes
tss,max of gemigliptin, dapagliflozin, empagliflozin
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite
Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax)of gemigliptin metabolite
Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration(Css,min) of gemigliptin metabolite
Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
metabolic ratio of gemigliptin
Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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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.
jungryul kim, doctor principal investigator
samsung seoul medical center
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 Gemigliptin, Dapagliflozin and Empagliflozin in people with Type 2 Diabetes Mellitus, run by LG Chem at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Jun 2018. 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 South Korea. 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?
Results are not available in the source record.
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 versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin (time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours). 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?
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 21 Jun 2018.