KATP channels blockers, PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators), SUR modulators(Sulfonylurea receptor modulators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Sanofi

Active Organization

Sanofi

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

Structure

Molecular FormulaC4H12ClN5

InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N

CAS Registry1115-70-4

View All Structures (2)

Clinical Trials associated with Glimepiride/Metformin Hydrochloride

CTR20190757 / Completed

格列美脲二甲双胍片在健康受试者中随机、开放、单剂量、两周期、两交叉空腹和餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-period, two-crossover bioequivalence study of glimepiride and metformin tablets in healthy subjects under fasting and fed conditions

主要目的：以法国赛诺菲-万安特公司生产Amaryl®M为参比制剂，对比华中药业生产的格列美脲二甲双胍片（受试制剂），考察健康志愿者单次口服格列美脲二甲双胍片在人体的血药浓度及主要药代动力学参数，并评价其生物等效性。次要目的：观察格列美脲二甲双胍片（受试制剂）和格列美脲二甲双胍片（参比制剂）在健康受试者中的安全性。

[Translation]

Primary objective: To compare Amaryl®M produced by Sanofi-Vanant in France with Glimepiride Metformin Tablets (test preparation) produced by Huazhong Pharmaceutical, to investigate the blood concentration and main pharmacokinetic parameters of Glimepiride Metformin Tablets in healthy volunteers after a single oral administration, and to evaluate their bioequivalence. Secondary objective: To observe the safety of Glimepiride Metformin Tablets (test preparation) and Glimepiride Metformin Tablets (reference preparation) in healthy subjects.

Start Date25 Apr 2019

Sponsor / Collaborator

Hubei Huazhong Pharmaceutical Co. Ltd.

NCT02395237 / WithdrawnPhase 1IIT

An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl® M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

Start Date01 May 2015

Sponsor / Collaborator

Pharmaceutical Research Unit, Jordan

[+1]

NCT01890629 / CompletedPhase 4

A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes

To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.

Start Date01 May 2013

Sponsor / Collaborator

LG Life Sciences Ltd.

100 Clinical Results associated with Glimepiride/Metformin Hydrochloride

100 Translational Medicine associated with Glimepiride/Metformin Hydrochloride

100 Patents (Medical) associated with Glimepiride/Metformin Hydrochloride

Literatures (Medical) associated with Glimepiride/Metformin Hydrochloride

01 Nov 2014·Pakistan journal of pharmaceutical sciences

A simple and convenient method for the simultaneous in vitro study of metformin and glimepiride tablets.

Article

Author: Ahmed, Rehan

A simple and convenient method was developed for the simultaneous determination of metformin HCl and glimepiride in tablet dosage form of different pharmaceuticals companies. This method was validated and proved to be applicable for assay determination in intermediate and finished staged. More over a single medium dissolution of metformin HCl and glimepiride was established and the media was evaluated for comparative studies for different formulations. Reverse phase HPLC equipped with UV detector was used for the determination of metformin HCl and glimepiride. A mixture of acetonitrile and ammonium acetate buffer 0.05M pH 3.0 was used as mobile phase at flow rate of 1.0ml/min. Promocil C18 5µ 100Aº 4.6 x 100mm C18 silica column was used and detection was carried out at 270nm. Method was found to be linear over the range of 4ppm to 16ppm for glimepiride and 170ppm to 680ppm for metformin HCl. Regression co-efficient were found to be 0.9949 and 0.9864 for glimepiride and metformin HCl respectively. Dissolution was performed in 500ml 0.2% sodium lauryl sulfate at 37°C for 45min using paddle apparatus. Dissolution of glimepiride was found to be 98.60% and 101.08% in Orinase Met1 tablet and Amaryl M tablet respectively whereas metformin was found 99.41% and 98.59% in Orinase Met 1 tablet and Amaryl M tablet. RSD for all the dissolutions was less than 2.0% after completion.

100 Deals associated with Glimepiride/Metformin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	-	Sanofi	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01561976 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	30	METLEAD ForteSR (METLEAD ForteSR-Fasting)	jrxkppdmbo(scukkpglsq) = eggozmjwrb vfmqnxjwfm (zxpeipassq, riqajfwnhq - gisdazpixa) View more	-	16 Oct 2017
				ForteSR (METLEAD ForteSR-Fed)	jrxkppdmbo(scukkpglsq) = fpqzofiwsh vfmqnxjwfm (zxpeipassq, juimgpqncv - yjlmjigieq) View more
NCT00612144 (Pubmed \| J Diabetes Investig)	Phase 4	Diabetes Mellitus, Type 2	209	Glimepiride/Metformin fixed-dose combination	(kzibxzsklp) = dobbhhhowu gppvyphloq (wbhegojgrv ) View more	-	01 Nov 2014
				Metformin uptitration	(kzibxzsklp) = wjtdlfalya gppvyphloq (wbhegojgrv ) View more

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