26 completed, 12 unknown. 19 Phase 1, 10 Phase 3, 5 Phase 4, 3 Not applicable, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 19 | Completed 13, Unknown 6 |
| Phase 3 | 10 | Completed 7, Unknown 3 |
| Phase 4 | 5 | Unknown 3, Completed 2 |
| Not applicable | 3 | Completed 3 |
| Phase 2 | 1 | Unknown 1 |
Follow this drug Literature Review of LC15-0444 trials Research Report on LC15-0444
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg - Fed Conditions, Healthy Volunteer | Phase 1 | Completed | LG Chem | 50 | 2025-09-29 | 2026-01-12 |
| Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes Dapagliflozin, Gemigliptin - Type2 Diabetes, Remodeling, Ventricular | Phase 4 | Unknown | Wonju Severance Christian Hospital | 122 | 2022-01-07 | 2023-08-01 |
| Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting), gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) - Healthy Volunteers | Phase 1 | Unknown | LG Chem | 28 | 2022-01-01 | 2021-11-03 |
| Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg. Gemigliptin tartrate sesquihydrate and metformin, gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release - Type 2 Diabetes | Phase 1 | Completed | LG Chem | 40 | 2020-08-19 | 2021-02-09 |
| A Study to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Who Have Inadequate Glycemic Control on Metformin Alone Gemigliptin 50mg, Dapagliflozin 10mg - Diabetes Mellitus, Type 2 | Phase 3 | Unknown | LG Chem | 468 | 2020-06-30 | 2020-02-19 |
| Effect of Gemigliptin Versus Glimepiride on Cardiac Diastolic Function in Patients With Type 2 Diabetes Gemigliptin, Glimepiride - Ejection Fraction | Phase 4 | Unknown | Seoul National University Bundang Hospital | 80 | 2020-01-01 | 2023-03-08 |
| Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting), Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed) - Type2 Diabetes | Phase 1 | Unknown | LG Chem | 24 | 2019-11-01 | 2019-08-28 |
| Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg. gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release, Gemigliptin tartrate sesquihydrate and metformin - Type2 Diabetes | Phase 1 | Unknown | LG Chem | 24 | 2019-11-01 | 2019-08-08 |
| An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I) Gemigliptin 25mg, Gemigliptin 50mg, Gemigliptin 100mg - Type 2 Diabetes Mellitus | Phase 1 | Completed | LG Chem | 48 | 2019-07-02 | 2020-03-03 |
| A Study to Evaluate the Efficacy and Safety of Gemigliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Dapagliflozin and Metformin (SOLUTION Study) Gemigliptin 50mg, Gemigliptin Placebo - Diabetes Mellitus, Type 2 | Phase 3 | Completed | LG Chem | 315 | 2019-05-13 | 2023-03-10 |
| Gemigliptin, Dapagliflozin, Empagliflozin DDI Study Gemigliptin, Dapagliflozin, Empagliflozin - Type 2 Diabetes Mellitus | Phase 1 | Unknown | LG Chem | 48 | 2018-04-05 | 2018-06-21 |
| 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) Gemigliptin 50mg, Dapagliflozin 10mg, Diet/exercise questionnaire - Type 2 Diabetes Mellitus | Phase 4 | Completed | LG Chem | 71 | 2017-08-09 | 2019-02-15 |
| Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification Gemigliptin - Diabetic Nephropathies | Not applicable | Completed | Bangkok Metropolitan Administration Medical College and Vajira Hospital | 201 | 2017-02-05 | 2021-01-14 |
| Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in Combination With Metformin in Type 2 DM (ZEUS II Study) Gemigliptin, Gemigliptin placebo, Metformin - Type 2 Diabetes Mellitus | Phase 3 | Completed | LG Life Sciences | 290 | 2016-10-17 | 2018-02-22 |
| BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone gemigliptin 50mg, rosuvastatin 20mg - Healthy | Phase 1 | Unknown | LG Life Sciences | 37 | 2016-03-01 | 2016-05-11 |
| An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers Gemigliptin, Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day, Metformin - Diabetes Mellitus, Type 2 | Phase 1 | Completed | Stendhal Americas, S.A. | 34 | 2016-01-15 | 2017-10-16 |
| Initial Combination of Gemigliptin and Metformin on Microbiota Change gemigliptin/metformin, glimepiride/metformin - Diabetes | Not applicable | Completed | Seoul National University Bundang Hospital | 70 | 2015-11-01 | 2021-11-22 |
| BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release - Healthy | Phase 1 | Unknown | LG Life Sciences | 25 | 2015-08-01 | 2016-02-02 |
| Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury Gemigliptin, Placebo, Cisplatin - Cancer, Cisplatin Adverse Reaction | Phase 2 / Phase 3 | Unknown | Seoul National University Bundang Hospital | 182 | 2014-12-01 | 2016-04-20 |
| BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release - Healthy | Phase 1 | Completed | LG Life Sciences | 29 | 2014-12-01 | 2015-02-03 |
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Diabetes Mellitus, Type 2 (17) · Diabetes Mellitus (3) · Acute Kidney Injury (1) · Diabetic Nephropathies (1) · Neoplasms (1) · Renal Insufficiency (1) · Vascular Calcification (1) · Ventricular Remodeling (1)
LG Life Sciences (20) · LG Chem (10) · Seoul National University Bundang Hospital (3) · Seoul National University Hospital (2) · Bangkok Metropolitan Administration Medical College and Vajira Hospital (1) · Stendhal Americas, S.A. (1) · Wonju Severance Christian Hospital (1)
South Korea (27) · Thailand (2) · China (1) · Germany (1) · Mexico (1)
Kyung-sang Yu, M.D,Ph.D (2) · Uthai Suvanakoot (2) · BW Lee (1) · Ignacio Conde-Carmona, MD (1) · JH Jo (1) · JH Jung (1) · JH Kim (1) · Jaehyen Kim (1) · Ki Young Na (1) · Kyun-Seop Bae, M.D., Ph.D. (1) · Kyung Sang Yu, MD, PhD (1) · Kyung-Sang Yu, M.D., Professor (1) · Kyung-Sang Yu, MD, PhD (1) · Min Kyong Moon (1)
PMID 25350224, PMID 22192641, PMID 24092928, PMID 24627290, PMID 25678778, PMID 26021829, PMID 30249366, PMID 30288156, PMID 33149182, PMID 34697593