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The objective of this study is to evaluate the efficacy and safety of dual add-on therapy with Gemigliptin 50 mg and Dapagliflozin 10 mg added to Metformin compared to add-on therapy with Gemigliptin 50 mg in combination with Metformin or Dapagliflozin 10 mg in combination with Metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin 50 mg and Dapagliflozin 10 mg | Experimental |
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| Gemigliptin 50 mg and Dapagliflozin placebo | Active Comparator |
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| Gemigliptin placebo and Dapagliflozin 10mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin 50mg | Drug | The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day |
| Measure | Description | Time Frame |
|---|---|---|
| Chages from baseline HbA1c at Week24 | Baseline to Week24 |
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Inclusion Criteria:
Patients with type 2 diabetes mellitus
Patients upper 19 years old
Patients who had taken Metformin(≥1000mg/day) more than 8 weeks and who have inadequate blood glucose control
Patients who have signed an informed consent themselves after receiving explanation about the clinical study
Patients who are applicable to one of the three in the following.
Exclusion Criteria:
Patients with type 1 diabetes mellitus, Diabetic ketoacidosis, Metabolic acidosis Diabetic coma, Diabetic pre-coma
Patients with Gestational diabetes, or secondary diabetes
Patients with NYHA Class II~IV congestive heart failure or arrhythmia requiring treatment
Patients whose TSH level is out of the normal range and who have thyroidal dysfunction requiring drug therapy
Patients with positive Serologic results of HBsAg, HCV Ab, HIV Ab test within 4 weeks prior to Visit 1 (Screening) or at Visit 1 (Screening)
Patients with Body Mass Index(BMI) #40 kg/m2
Patients who are receiving intravenous iodine contrast agents within 48 hours prior to Visit 1(Screening) or planned during the clinical trial period (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.).
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 clinically significant dehydration, diarrhea, and vomiting at the time of Visit 1(Screening)
Patients with pituitary insufficiency or adrenal insufficiency at the time of Visit 1(Screening)
Patients with a history of alcoholism or drug addiction within 1 years 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
Patients with a history of hypersensitivity reactions to the drugs below
Patients who were administered the drugs below
Patients who had been administered anti-obesity drugs within 12 weeks prior to Visit 1(Screening)
Patients who have undergone bariatric surgery within the 1 year prior to Visit 1 (Screening) or are scheduled during the trial
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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Eunjoo Cho | Contact | +82-2-6987-4284 | eunjoo.cho@lgchem.com |
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|
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| Dapagliflozin 10mg | Drug | The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day |
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| 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 |
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