Type 2 Diabetes MellitusPhase 4NCT03202563
Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)
A Phase 4 study testing Gemigliptin 50mg, Dapagliflozin 10mg and Diet/exercise questionnaire in people with Type 2 Diabetes Mellitus, run by LG Chem at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the efficacy on glycemic variability and safety of gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin 10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone or diabetes medication naïve… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Gemigliptin 50mg, Dapagliflozin 10mg and Diet/exercise questionnaire
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2017to 7 Dec 2018
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus of 20~70years of age at the time of Visit 1 (Screening)
- Patients with HbA1c measured in the local lab ranged from 7 to 11%satisfying the following conditions at the time of Visit 1(Screening)
- Type 2 diabetes mellitus medication naïve patients or patients who had not taken diabetes medication other than metformin within 8 weeks prior to Visit 1(Screening)
- For patients who have been taking metformin alone within 12 weeks prior to visit 1(Screening) and had taken at least 1000 mg of metformin daily without dose adjustment for 4 weeks prior to Visit 1(Screening)
- Patients who have signed an informed consent themselves after receiving explanation about the objectives, methods, effects, etc. of the clinical study
- Patients who are applicable to one of the three in the following. 1) Surgically infertile patients 2) Postmenopausal female patients of ≥45 years of age for whom ≥2 years elapsed since their last menstruation 3) Premenopausal fertile female patients or surgically non-infertile male patients who have agreed to use at least 2 kinds of contraceptive measures (certainly including one of the barrier methods) to avoid pregnancy until 14 days after the last dose of the investigational product
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- Barrier methods: Condom, Diaphragm, Cervical cap(Pessary), Spermicide
- Hormonal methods: Pills, Injection(Depot), Skin patch, Hormonal implant(Implanon), Vaginal ring
- Intrauterine Devices(IUDs): Cooper IUD(Loop), Hormonal IUD(Mirena)
- Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinence
Who cannot join
- Patients with type 1 diabetes mellitus*, Diabetic ketoacidosis, Diabetic coma, Diabetic pre-coma
- Patients with Gestational diabetes, or secondary diabetes
- Patients with Body Mass Index(BMI) >40 kg/m2 at the time of Visit 1(Screening)
- Patients with a history of the following
- Patients with NYHA Class III, IV congestive heart failure or arrhythmia requiring treatment at the time of Visit 1(Screening)
- Patients whose TSH level is out of the normal range and who have thyroidal dysfunction requiring drug therapy at the time of Visit 1(Screening) (However, those who have been taking thyroid hormone at a fixed dose since previous 6 weeks prior to Visit 1[Screening] and whose TSH level is within the normal range can participate in the study.)
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- Patients with a glomerular filtration rate (eGFR) less than 60 mL/min /1.73 m2, dnd stage renal disease, dialysis or with renal disease that may result from conditions such as cardiovascular shock, acute myocardial infarction and sepsis, or patients with renal insufficiency at the time of Visit 1(Screening)
- Patients who are receiving intravenous iodine contrast agents at the time of visit 1(Screening) or planned during the clinical trial period (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.) ). For patients who have received this test, they can re-evaluate the renal function 48 hours after the test and only participate in clinical trials after they have been found to be normal.
- Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at the time of Visit 1(Screening)
- Patients on drug therapy due to gastrointestinal disturbance including dehydration, diarrhea, and vomiting at the time of Visit 1(Screening) Patients with severe infection or severe trauma at the time of Visit 1(Screening)
- Patients with malnutrition status, starvation status, weakness status, pituitary insufficiency or adrenal insufficiency at the time of Visit 1(Screening)
- Patients with a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma within 12 weeks prior to Visit 1(Screening)
- Patients with a history of myocardial infarction, unstable angina, and coronary artery bypass graft(CABG) within 12 weeks prior to Visit 1(Screening)
- Patients who had had a surgical operation within 4 weeks prior to Visit 1(Screening) (excluding minor surgeries without restriction on food and fluid intake) or who are scheduled to have a significant surgery during the study period
- Patients with a history of alcoholism or drug addiction within 12weaks prior to Visit 1(Screening)
- Patients with a history of malignant tumors within 5 years prior to Visit 1(Screening). However, patients with basal cell or squamous cell skin cancer, or in situ cervical cancer treated properly can participate in the study.
- Patients with the outcomes of the laboratory tests performed at Visit 1(Screening) applicable to the criteria below
- Bilirubin >2 × upper limit of normal(ULN)
- AST/ALT >3 × ULN
- Patients with a history of hypersensitivity reactions to the drugs below
- Gemigliptin or drugs belonging to dipeptidyl-peptidase4(DPP4) inhibitors
- Dapagliflozin or drugs belonging to Sodium/glucose co transport-2(SGLT-2) inhibitor
- Metformin or drugs belonging to biguanides
- Patients who were administered the drugs below
- Patients who had been administered anti-obesity drugs within 4 weeks prior to Visit 1(Screening)
- Patients who had been administered insulin or GLP-1 analogues within 8 weeks prior to Visit 1(Screening)
- Patients who had been administered warfarin, dicoumarin, and digoxin within 4 weeks prior to Visit 1(Screening)
- Patients who are being administered any of the strong CYP3A4 inducers (rifampicin[rifampin], dexamethasone, phenytoin, carbamazepine, rifabutin, phenobarbital) at the time of Visit 1(Screening)
- Patients who had been being administered glucocorticoids continuously within 2 weeks prior to Visit 1(Screening) or who are required to take glucocorticoids continuously in the future
- Patients with a genetic problems such as Galactose intolerance, Lapp lactose deficiency, Glucose-galactose malabsorption)
- Female patients who are pregnant or lactating
- Patients who have an experience of participation in another clinical study within 12 weeks prior to Visit1(screening)
- Patients who are otherwise considered to be ineligible for this study on investigators' judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Phase 4 Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin 50mg q.d., Versus Dapagliflozin 10mg q.d. Added to Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Diabetes Medication Naïve Patient
The objective of this study is to evaluate the efficacy on glycemic variability and safety of gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin 10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone or diabetes medication naïve patient
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Gemigliptin 50mg, Dapagliflozin 10mg, Diet/exercise questionnaire, Continuous Glucose Monitoring System(CGMS), Metformin
- 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.
Gemigliptin 50mgDrug
For patients who have been randomized to Gemigliptin(Experimental arm), the patients continue to take a gemigliptin 50mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91))
Dapagliflozin 10mgDrug
For patients who have been randomized to Dapagliflozin(Active Comparator arm), the patients continue to take a dapagliflozin 10mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91))
Diet/exercise questionnaireProcedure or surgery
doing exercise with about intermediate intensity(50~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regular diet without greater changes in life style as much as possible during the whole study period.
the questionnaire regarding diet/exercise will be collected at -day 6, day 1, day29, day85, day 91
Continuous Glucose Monitoring System(CGMS)Device
For patients who have been screening completely, the subjects will be attached CGMS(ipro-2) twice from Visit 2(-day 6) to Visit 3(day 1) and Visit 5(day 85) to Visit 6(day 91)
MetforminDrug
For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin 50mg | Experimental | the subjects should visit a study site 4 times during the treatment period for about 12 weeks in total.
Drug: Gemigliptin Drug: Metformin Procedure: Diet/exercise questionnaire Procedure: Continuous Glucose Monitoring System(CGMS) Receives: Drug: Gemigliptin 50mg; Procedure: Diet/exercise questionnaire; Device: Continuous Glucose Monitoring System(CGMS); Drug: Metformin |
| Dapagliflozin 10mg | Active comparator | the subjects should visit a study site 4 times during the treatment period for about 12 weeks in total.
Drug: Dapagliflozin Drug: Metformin Procedure: Diet/exercise questionnaire Procedure: Continuous Glucose Monitoring System(CGMS) Receives: Drug: Dapagliflozin 10mg; Procedure: Diet/exercise questionnaire; Device: Continuous Glucose Monitoring System(CGMS); Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12
MAGE will be calculated from MBG which has been measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2~visit 3, visit 5~visit 6)
Measured: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
Secondary outcomes (5)
Changes from baseline MBG(Mean Blood Glucose) at week 12
MBG is a mean blood glucose measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2~visit 3, visit 5~visit 6)
Measured: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
Changes from baseline SD(Standard Deviation) at week 12
SD is a standard deviation of MBG measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2~visit 3, visit 5~visit 6)
Measured: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
Changes from baseline CV(Coefficient of variance) at week 12
CV is a coefficient of variance which is MBG divided by SD measured by MBG during CGM period(visit 2~visit 3, visit 5~visit 6)
Measured: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
Changes from baseline hsCRP at week 12
Measured: baseline (visit 2) and week 12 (visit 5)
Changes from baseline Nitrotyrosine at week 12
Measured: baseline (visit 2) and week 12 (visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start9 Aug 2017
- Primary completion13 Jul 2018
- Study completion7 Dec 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaehyen Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202563
- Sponsor's protocol ID
- LG-DPCL017
- Status last verified
- May 2018
- First submitted
- 26 Jun 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Phase 4 Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin 50mg q.d., Versus Dapagliflozin 10mg q.d. Added to Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Diabetes Medication Naïve Patient
- ClinicalTrials.gov ID
- NCT03202563
- Acronym / sponsor ID
- LG-DPCL017
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 28 Jun 2017 (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.
The objective of this study is to evaluate the efficacy on glycemic variability and safety of gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin 10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone or diabetes medication naïve patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin 50mg | Experimental | Drug: Gemigliptin 50mg, Procedure: Diet/exercise questionnaire, Device: Continuous Glucose Monitoring System(CGMS), Drug: Metforminthe subjects should visit a study site 4 times during the treatment period for about 12 weeks in total. Drug: Gemigliptin Drug: Metformin Procedure: Diet/exercise questionnaire Procedure: Continuous Glucose Monitoring System(CGMS) |
| Dapagliflozin 10mg | Active comparator | Drug: Dapagliflozin 10mg, Procedure: Diet/exercise questionnaire, Device: Continuous Glucose Monitoring System(CGMS), Drug: Metforminthe subjects should visit a study site 4 times during the treatment period for about 12 weeks in total. Drug: Dapagliflozin Drug: Metformin Procedure: Diet/exercise questionnaire Procedure: Continuous Glucose Monitoring System(CGMS) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with type 2 diabetes mellitus of 20~70years of age at the time of Visit 1 (Screening)
- Patients with HbA1c measured in the local lab ranged from 7 to 11%satisfying the following conditions at the time of Visit 1(Screening)
- Patients who have signed an informed consent themselves after receiving explanation about the objectives, methods, effects, etc. of the clinical study
- Patients who are applicable to one of the three in the following. 1) Surgically infertile patients 2) Postmenopausal female patients of ≥45 years of age for whom ≥2 years elapsed since their last menstruation 3) Premenopausal fertile female patients or surgically non-infertile male patients who have agreed to use at least 2 kinds of contraceptive measures (certainly including one of the barrier methods) to avoid pregnancy until 14 days after the last dose of the investigational product
Key exclusion criteria (33 listed)
- Patients with type 1 diabetes mellitus*, Diabetic ketoacidosis, Diabetic coma, Diabetic pre-coma
- Patients with Gestational diabetes, or secondary diabetes
- Patients with Body Mass Index(BMI) >40 kg/m2 at the time of Visit 1(Screening)
- Patients with a history of the following
- Patients with the outcomes of the laboratory tests performed at Visit 1(Screening) applicable to the criteria below
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 |
|---|---|---|
| Gemigliptin 50mgFor patients who have been randomized to Gemigliptin(Experimental arm), the patients continue to take a gemigliptin 50mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91)) | Drug | Gemigliptin 50mg |
| Dapagliflozin 10mgFor patients who have been randomized to Dapagliflozin(Active Comparator arm), the patients continue to take a dapagliflozin 10mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91)) | Drug | Dapagliflozin 10mg |
| Diet/exercise questionnairedoing exercise with about intermediate intensity(50~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regular diet without greater changes in life style as much as possible during the whole study period. the questionnaire regarding diet/exercise will be collected at -day 6, day 1, day29, day85, day 91 | Procedure or surgery | Dapagliflozin 10mg, Gemigliptin 50mg |
| Continuous Glucose Monitoring System(CGMS)For patients who have been screening completely, the subjects will be attached CGMS(ipro-2) twice from Visit 2(-day 6) to Visit 3(day 1) and Visit 5(day 85) to Visit 6(day 91) | Device | Dapagliflozin 10mg, Gemigliptin 50mg |
| MetforminFor patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study | Drug | Dapagliflozin 10mg, Gemigliptin 50mg |
Primary outcome
Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12
Time frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
MAGE will be calculated from MBG which has been measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2~visit 3, visit 5~visit 6)
5 secondary outcomes
Changes from baseline MBG(Mean Blood Glucose) at week 12
Time frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
Changes from baseline SD(Standard Deviation) at week 12
Time frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
Changes from baseline CV(Coefficient of variance) at week 12
Time frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)
Changes from baseline hsCRP at week 12
Time frame: baseline (visit 2) and week 12 (visit 5)
Changes from baseline Nitrotyrosine at week 12
Time frame: baseline (visit 2) and week 12 (visit 5)
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 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jaehyen Kim principal investigator
Samsung 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 4 study testing Gemigliptin 50mg, Dapagliflozin 10mg and Diet/exercise questionnaire 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 10 inclusion and 33 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 15 Feb 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12 (time frame: baseline (visit 2~visit3) and week 12 (visit 5~visit 6)). 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 15 Feb 2019.