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
Overview
- Phase
- Phase 4
- Intervention
- Gemigliptin 50mg
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- LG Chem
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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 patient
Investigators
Eligibility Criteria
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)
- •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
- •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
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 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.)
- •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)
Arms & Interventions
Gemigliptin 50mg
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)
Intervention: Gemigliptin 50mg
Gemigliptin 50mg
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)
Intervention: Diet/exercise questionnaire
Gemigliptin 50mg
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)
Intervention: Continuous Glucose Monitoring System(CGMS)
Gemigliptin 50mg
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)
Intervention: Metformin
Dapagliflozin 10mg
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)
Intervention: Dapagliflozin 10mg
Dapagliflozin 10mg
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)
Intervention: Diet/exercise questionnaire
Dapagliflozin 10mg
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)
Intervention: Continuous Glucose Monitoring System(CGMS)
Dapagliflozin 10mg
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)
Intervention: Metformin
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Changes from baseline CV(Coefficient of variance) at week 12(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))
- Changes from baseline MBG(Mean Blood Glucose) at week 12(baseline (visit 2~visit3) and week 12 (visit 5~visit 6))
- Changes from baseline SD(Standard Deviation) at week 12(baseline (visit 2~visit3) and week 12 (visit 5~visit 6))