Zemimet SR (gemigliptin/metformin sustained release) / LG Chem - LARVOL DELTA

INTESTINE: Initial Combination of Gemigliptin and Metformin on Microbiota Change (clinicaltrials.gov) - P=N/A; N=70; Completed; Sponsor: Seoul National University Bundang Hospital; Active, not recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg. (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: LG Chem; Not yet recruiting ➔ Completed; N=60 ➔ 40; Trial completion date: Dec 2020 ➔ Sep 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: LG Life Sciences; Initiation date: Dec 2012 ->Dec 2014 ; Trial primary completion date: Dec 2012 ->Jan 2015

Trial initiation date • Trial primary completion date • Biosimilar • Hematological Malignancies

Pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/metformin sustained release 25/500 mg compared to the loose combination in healthy male subjects. (PubMed, Transl Clin Pharmacol) - P1 | "In conclusion, the PK/PD characteristics of gemigliptin and metformin were similar in FDC tablets and loose combination both in fasted and fed states. ClinicalTrials.gov Identifier: NCT03355014."

Clinical • Journal • PK/PD data

INTESTINE: Initial Combination of Gemigliptin and Metformin on Microbiota Change (clinicaltrials.gov) - P=N/A; N=70; Active, not recruiting; Sponsor: Seoul National University Bundang Hospital; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date

Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg. (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: LG Chem

Clinical • New P1 trial

INTESTINE: Initial Combination of Gemigliptin and Metformin on Microbiota Change (clinicaltrials.gov) - P=N/A; N=70; Recruiting; Sponsor: Seoul National University Bundang Hospital; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Apr 2019 ➔ Dec 2019

Clinical • Combination therapy • Trial completion date • Trial primary completion date

Pharmacokinetic Interactions Between Gemigliptin and Metformin, and Potential Differences in the Pharmacokinetic Profile of Gemigliptin Between the Mexican and Korean Populations: A Randomized, Open-Label Study in Healthy Mexican Volunteers. (PubMed, Clin Ther) - P1; "The results of this study support, in ethnically different populations, the absence of drug-drug interactions between gemigliptin and metformin previously shown in Korean healthy volunteers. Considering the flat effect-concentration curve and wide therapeutic range of gemigliptin, the pharmacokinetic profile of gemigliptin observed in healthy Mexican and Korean subjects suggests that gemigliptin use in Mexican patients may be associated with outcomes, in terms of efficacy and tolerability, similar to those observed in the Korean population. ClinicalTrials.gov identifier: NCT03310749."

Clinical • Journal • PK/PD data

Efficacy and safety of gemigliptin as add-on therapy to insulin with or without metformin in patients with type 2 diabetes mellitus (ZEUS II study). (PubMed, Diabetes Obes Metab) - "The incidences of overall adverse events and the number of hypoglycaemic adverse events were similar among the study groups. Gemigliptin added on to insulin alone or insulin in combination with metformin showed superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus without causing weight gain or increasing the incidence of hypoglycaemia."

Clinical • Journal

Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: LG Chem

Clinical • New P1 trial

Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg. (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: LG Chem

Clinical • New P1 trial

Pharmacokinetic comparison of gemigliptin 50 mg and metformin 500 mg as a fixed-dose combination and loose combination. (PubMed, Int J Clin Pharmacol Ther) - "When comparing the AUC and C of gemigliptin, LC15-0636, and metformin, the 90% CIs were all within the range of 0.8 - 1.25, which is the commonly accepted range for evaluating bioequivalence."

Journal • PK/PD data