Clinical trials: Gemigliptin
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
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
Diabetes
Initial Combination of Gemigliptin and Metformin on Microbiota Change
The purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2…
- Trial name
- INTESTINE (NCT02609815)
- Testing
- gemigliptin/metformin, glimepiride/metformin
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Seoul National University Bundang Hospital
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 Mellitus
Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia
This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes. The investigators will measure systemic endotoxin level and lipid level after ingestion of high fat diet to evaluate the effect of…
- Trial name
- NCT02186080
- Testing
- Gemigliptin
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Seoul National University Hospital
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