Clinical trials: Gemigliptin
Type 2 Diabetes Mellitus
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
The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes.
- Trial name
- NCT02089126
- Testing
- Gemigliptin/Glimepiride combination
- Where
- South Korea
- Volunteers
- 230 people
- Sponsor
- LG Life Sciences
Type2 Diabetes
Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the…
- Trial name
- NCT04070794
- Testing
- Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting), Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
Type 2 DM Patients With Moderate or Severe Renal Impairment
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)
Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or…
- Trial name
- GUARD (NCT01968044)
- Testing
- Gemigliptin
- Where
- South Korea
- Volunteers
- 132 people
- Sponsor
- LG Life Sciences
Type 2 Diabetes Mellitus
Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d
The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other…
- Trial name
- NCT01787396
- Testing
- Gemigliptin 50mg, Metformin
- Where
- South Korea
- Volunteers
- 433 people
- Sponsor
- LG Life Sciences
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone
This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy…
- Trial name
- NCT01662674
- Testing
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release
- Where
- South Korea
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Type 2 Diabetes Mellitus
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)
To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.
- Trial name
- NCT03864432
- Testing
- Gemigliptin 25mg, Gemigliptin 50mg, Gemigliptin 100mg
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy, Fasting
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers
This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under…
- Conditions
- Healthy, Fasting, Fed
- Trial name
- NCT07396844
- Testing
- Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg
- Where
- Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Chem
Diabetes Mellitus, Type 2
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
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…
- Trial name
- NCT04255238
- Testing
- Gemigliptin 50mg, Dapagliflozin 10mg
- Volunteers
- 468 people
- Sponsor
- LG Chem
Healthy Male Volunteers
BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone
This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each…
- Trial name
- NCT03355014
- Testing
- Combination of gemigliptin/metformin HCl sustained release 50/1000mg, Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
- Where
- South Korea
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- LG Chem
Diabetes Mellitus, Type 2
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)
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…
- Trial name
- NCT03842267
- Testing
- Gemigliptin 50mg
- Where
- South Korea
- Volunteers
- 315 people
- Sponsor
- LG Chem
Type 2 Diabetes Mellitus
Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was started with an initial 2 weeks of exercise/diet program followed by another 2…
- Trial name
- NCT01601990
- Testing
- LC15-0444 50mg qd
- Where
- South Korea
- Volunteers
- 189 people
- Sponsor
- LG Life Sciences
Type 2 Diabetes Mellitus
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
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was a screening period started with an initial 2 weeks of exercise/diet program…
- Trial name
- NCT01602003
- Testing
- LC15-0444 25mg bid, LC15-0444 50mg qd, Sitagliptin 100mg qd
- Where
- South Korea
- Volunteers
- 425 people
- Sponsor
- LG Life Sciences
Type 2 Diabetes Mellitus
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)
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…
- Trial name
- NCT03202563
- Testing
- Gemigliptin 50mg, Dapagliflozin 10mg, Diet/exercise questionnaire
- Where
- South Korea
- Volunteers
- 71 people
- Sponsor
- LG Chem
Type 2 Diabetes Mellitus
Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin
Primary Objective: To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.
- Trial name
- NCT02343926
- Testing
- GEMIGLIPTIN LS15-0444, vildagliptin, metformin
- Where
- Russia
- Volunteers
- 443 people
- Sponsor
- Sanofi
T2DM
Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
- Trial name
- NCT04544319
- Testing
- Zemiglo 50mg and Forxiga 10mg, Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.
- Trial name
- NCT02670070
- Testing
- gemigliptin 50mg, rosuvastatin 20mg
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2…
- Trial name
- NCT02670018
- Testing
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release
- Where
- South Korea
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Male Volunteers
Pharmacokinetic Drug Interaction Study in Healthy Male Subjects
A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.
- Trial name
- NCT01426906
- Testing
- Ketoconazole, rifampicin
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects
The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.
- Trial name
- NCT01825850
- Testing
- Gemigliptin, Irbesartan
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Volunteers
Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg
A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in…
- Trial name
- NCT05105698
- Testing
- gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting), gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Chem