20 completed, 4 unknown, 1 terminated. 25 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 25 | Completed 20, Unknown 4, Terminated 1 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy LBAL, Humira® - Arthritis, Rheumatoid | Phase 3 | Completed | LG Life Sciences | 383 | 2016-04-13 | 2021-03-15 |
| A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX) LBEC0101 - Rheumatoid Arthritis | Phase 3 | Completed | LG Life Sciences | 148 | 2016-04-01 | 2018-07-06 |
| A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy Enbrel, LBEC0101 - Arthritis, Rheumatoid | Phase 3 | Unknown | LG Life Sciences | 372 | 2015-02-01 | 2016-01-06 |
| 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 |
| Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome Eutropin, Genotropin - Prader-Willi Syndrome | Phase 3 | Completed | LG Life Sciences | 34 | 2014-06-01 | 2019-06-27 |
| Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes Gemigliptin/Glimepiride combination - Type 2 Diabetes Mellitus | Phase 3 | Unknown | LG Life Sciences | 230 | 2014-06-01 | 2014-03-17 |
| Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE) Gemigliptin and/or Rosuvastatin - Type 2 Diabetes, Dyslipidemia | Phase 3 | Completed | LG Life Sciences | 290 | 2014-05-01 | 2016-10-18 |
| A Clinical Trial to Evaluate the Safety and Efficacy of Retreatment With Intra-articular LBSA0103 Injections in the Patients With Osteoarthritis of the Knee LBSA0103 (BDDE cross-linked sodium hyaluronate gel) - Osteoarthritis of Knee | Phase 3 | Completed | LG Life Sciences | 174 | 2014-04-01 | 2015-09-09 |
| Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin Gemigliptin, Gemigliptin placebo - T2DM | Phase 3 | Completed | LG Life Sciences | 219 | 2014-01-01 | 2016-04-19 |
| A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study) Gemigliptin, Placebo to Linagliptin - Type 2 DM Patients With Moderate or Severe Renal Impairment | Phase 3 | Completed | LG Life Sciences | 132 | 2013-10-01 | 2016-03-23 |
| Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d Gemigliptin 50mg, Placebo(Metformin), Metformin - Type 2 Diabetes Mellitus | Phase 3 | Completed | LG Life Sciences | 433 | 2013-04-01 | 2015-04-03 |
| To Assess the Anti-adhesive Effect and Safety of Protescal Protescal - Laparoscopic Myomectomy | Phase 3 | Terminated | LG Life Sciences | 50 | 2012-09-01 | 2016-03-11 |
| Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Lercanidipine 10mg, Lercanidipine10mg /Valsartan 80mg, Lercanidipine 10mg /Valsartan 160mg - Hypertension | Phase 3 | Completed | LG Life Sciences | 449 | 2012-05-01 | 2013-08-28 |
| Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia Valsartan 160mg, Rosuvastatin 20mg, Valsartan 160mg placebo - Hypertension,, Hyperlipidemia | Phase 3 | Completed | LG Life Sciences | 168 | 2012-04-01 | 2014-12-15 |
| Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis Placebo, Hyruan Plus, LBSA0103 - Osteoarthritis of the Knee | Phase 3 | Completed | LG Life Sciences | 287 | 2011-12-01 | 2013-01-17 |
| Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes Placebo group(once daily), LC15-0444 50mg qd - Type 2 Diabetes Mellitus | Phase 3 | Completed | LG Life Sciences | 189 | 2009-12-01 | 2012-05-18 |
| Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes LC15-0444 25mg bid, LC15-0444 50mg qd, Sitagliptin 100mg qd - Type 2 Diabetes Mellitus | Phase 3 | Completed | LG Life Sciences | 425 | 2009-12-01 | 2012-05-18 |
| A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants Eutravac - Healthy Infants | Phase 3 | Completed | LG Life Sciences | 289 | 2009-08-01 | 2013-07-11 |
| Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study LBVH0101 (Hib vaccine), Hiberix™ Vaccine - Infectious Disease by Haemophilus Influenzae Type b | Phase 3 | Completed | LG Life Sciences | 122 | 2008-07-01 | 2010-12-01 |
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Diabetes Mellitus, Type 2 (7) · Dwarfism, Pituitary (4) · Arthritis, Rheumatoid (3) · Hypertension (2) · Osteoarthritis, Knee (2) · Pituitary Diseases (2) · Communicable Diseases (1) · Dyslipidemias (1) · Hyperlipidemias (1) · Infections (1) · Influenza, Human (1) · Neoplasms (1) · Orthomyxoviridae Infections (1) · Prader-Willi Syndrome (1) · RNA Virus Infections (1)
LC15-0444 (8) · Growth Hormone (2) · HibTITER protein, Haemophilus influenzae (2) · Human Growth Hormone (2) · LBEC0101 (2) · Metformin (2) · Valsartan (2) · Adalimumab (1) · BID protein, human (1) · Cisplatin (1) · Etanercept (1) · Euvax-B (1) · Hepatitis B Vaccines (1) · Rosuvastatin Calcium (1) · Sitagliptin Phosphate (1)
South Korea (19) · Japan (2) · United States (2)
HJ Ji, PhD (2) · Ference Peter, MD (1) · Ki Young Na (1) · Se Hyun Baek, MD, PhD (1) · Sun Woo Kim, MD, PhD (1)
PMID 22245607, PMID 24092928, PMID 24170106, PMID 26021829, PMID 26164786, PMID 28549436, PMID 29259050, PMID 31113455, PMID 31511031