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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin 50mg | Drug | 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline (visit 2~visit3) and week 12 (visit 5~visit 6) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline (visit 2~visit3) and week 12 (visit 5~visit 6) |
| Changes from baseline SD(Standard Deviation) at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of HbA1c at each visit | values of parameters at the corresponding visit - values of parameters at visit 2(baseline) | baseline(visit 2), week 5(visit 4), week 13(visit 5) |
| Changes of Fasting plasma glucose at each visit |
Inclusion Criteria:
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
Exclusion Criteria:
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
Patients with a history of hypersensitivity reactions to the drugs below
Patients who were administered the drugs below
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
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| Name | Affiliation | Role |
|---|---|---|
| Jaehyen Kim | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
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| Dapagliflozin 10mg | Drug | 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 questionnaire | Procedure | 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) |
|
| Metformin | Drug | 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 |
|
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) |
| 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) | baseline (visit 2~visit3) and week 12 (visit 5~visit 6) |
| Changes from baseline hsCRP at week 12 | baseline (visit 2) and week 12 (visit 5) |
| Changes from baseline Nitrotyrosine at week 12 | baseline (visit 2) and week 12 (visit 5) |
values of parameters at the corresponding visit - values of parameters at visit 2(baseline)
| baseline(visit 2), week 5(visit 4), week 13(visit 5) |
| Changes of Fasting serum insulin at each visit | values of parameters at the corresponding visit - values of parameters at visit 2(baseline) | baseline(visit 2), week 5(visit 4), week 13(visit 5) |
| Changes of Glycated albumine at each visit | values of parameters at the corresponding visit - values of parameters at visit 2(baseline) | baseline(visit 2), week 5(visit 4), week 13(visit 5) |
| Changes of baseline HOMA-β at week 13 | baseline(visit 2), week 13(visit 5) |
| Changes of baseline HOMA-IR at week 13 | baseline(visit 2), week 13(visit 5) |
| Changes of baseline LDL-C at week 13 | baseline(visit 2), week 13(visit 5) |
| Changes of baseline HDL-C at week 13 | baseline(visit 2), week 13(visit 5) |
| Changes of baseline Total Cholesterol at week 13 | baseline(visit 2), week 13(visit 5) |
| Changes of baselineTriglyceride at week 13 | baseline(visit 2), week 13(visit 5) |
| Changes of baseline BMI at week 13 | baseline(visit 2), week 13(visit 5) |
| Changes of baseline Body weight at week 13 | baseline(visit 2), week 13(visit 5) |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
| C529054 | dapagliflozin |
| D000095583 | Continuous Glucose Monitoring |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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