Clinical trials: Gemigliptin
Diabetes Mellitus, Type 2, Dyslipidemias
BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.
To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.
- Trial name
- NCT03867942
- Testing
- Monolayer group, Bilayer group
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Pharmacokinetic Drug Interaction Between LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each…
- Trial name
- NCT01001013
- Testing
- LC15-0444, Pioglitazone
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Type 2 Diabetes Mellitus
Observational Study Gemigliptin in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
The aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in Korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings
- Trial name
- NCT05281029
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- LG Chem
T2DM
Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin
After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination…
- Trial name
- NCT01990469
- Testing
- Gemigliptin
- Volunteers
- 219 people
- Sponsor
- LG Life Sciences
Healthy Volunteers, Fasting Conditions
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
- Trial name
- NCT07399470
- Testing
- Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg
- Where
- South Korea
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration…
- Trial name
- NCT01426399
- Testing
- LC15-0444, Metformin, LC15-0444+Metformin
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.
- Trial name
- NCT01595880
- Testing
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release
- Where
- South Korea
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Fed Conditions, Healthy Volunteer
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
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions in healthy volunteers
- Trial name
- NCT07333742
- Testing
- Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LG Chem
Type 2 Diabetes, Dyslipidemia
Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)
To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia
- Trial name
- NCT02126358
- Testing
- Gemigliptin and/or Rosuvastatin
- Where
- South Korea
- Volunteers
- 290 people
- Sponsor
- LG Life Sciences
T2DM (Type 2 Diabetes Mellitus)
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests.
- Trial name
- NCT06141980
- Testing
- DWP16001 0.3 mg
- Volunteers
- 134 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Hepatic Impairment
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
- Trial name
- NCT02004587
- Testing
- Gemigliptin
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Type 2 Diabetes
Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
- Trial name
- NCT01747083
- Testing
- FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Diabetes Mellitus, Type 2
An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers
This is an open, randomized (randomization ratio: 1:1), multiple dose, three way, three period cross over study to assess the potential for drug drug interactions between gemigliptin (a DPP-IV inhibitor mainly metabolized by…
- Trial name
- NCT03310749
- Testing
- Gemigliptin, Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day, Metformin
- Where
- Mexico
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Stendhal Americas, S.A.
Healthy
Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] LC15-0444
This was an open-label, non-randomised, single-dose study in 6 healthy male subjects. Subjects attended a screening visit within 28 days before drug administration.
- Trial name
- NCT01603238
- Testing
- [14C]-LC15-0444
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Type2 Diabetes
Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
[Objectives]Primary: To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab.
- Trial name
- NCT04050098
- Testing
- gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release, Gemigliptin tartrate sesquihydrate and metformin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects
The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.
- Trial name
- NCT01768455
- Testing
- Gemigliptin and Glimepiride, Glimepiride
- Where
- South Korea
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Type 2 Diabetes Mellitus
Observational Study of Triple Combination Therapy of Zemidapa Tab. and Metformin in Type 2 Diabetes Mellitus Patients
The aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of Zemidapa Tab. and Metformin in patients with type 2 diabete mellitus
- Trial name
- NCT06495281
- Where
- South Korea
- Volunteers
- 2,044 people
- Sponsor
- LG Chem
Type 2 Diabetes Mellitus
An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin
The primary objective of the study is to investigate cardiovascular safety of gemigliptin by evaluating the time until patients report with major adverse cardiovascular events (MACE) in T2DM patients treated with gemigliptin.
- Trial name
- NCT02290301
- Testing
- gemigliptin
- Where
- South Korea
- Volunteers
- 5,180 people
- Sponsor
- LG Life Sciences
Type 2 Diabetes
Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab.
- Trial name
- NCT04317703
- Testing
- Gemigliptin tartrate sesquihydrate and metformin, gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release
- Where
- Thailand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin
Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects
- Trial name
- NCT01823133
- Testing
- gemigliptin only, rosuvastatin only, gemigliptin and rosuvastatin
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences