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The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with dapagliflozin and metformin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin 50mg | Active Comparator |
| |
| Gemigliptin Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin 50mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline HbA1c at week 24 | Baseline (week 0) and week 24 |
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Inclusion Criteria:
Patients with type 2 diabetes mellitus of upper 19 years old at the time of Visit 1 (Screening)
Visit 1 (Screening) Patients who had taken Dapagliflozin 10mg/day and Metformin(≥1000mg/day) more than 8 weeks and who have inadequate blood glucose control at 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, Metabolic acidosis 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 positive Serologic results of HBsAg, HCV Ab, HIV Ab test within 4 weeks prior to Visit 1 (Screening) or at 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG chem | Seoul | Gangseo-Gu | 07795 | South Korea |
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|
| Gemigliptin Placebo | Drug |
|
|
| 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 |
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