[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of gliclazide tablets in Chinese healthy subjects under fasting/fed conditions

主要目的：以珠海润都制药股份有限公司生产的格列齐特片（规格：40 mg）为受试制剂，以 Dainippon Sumitomo Pharma Co., Ltd.持证的格列齐特片（商品名：Glimicron®，规格：40mg）为参比制剂，在空腹/餐后状态下考察两制剂在健康受试者中的生物等效性。次要目的：观察口服受试制剂格列齐特片（规格：40mg）和参比制剂格列齐特片（商品名：Glimicron®，规格：40mg）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the bioequivalence of the two preparations in healthy subjects in the fasting/postprandial state, using gliclazide tablets (specification: 40 mg) produced by Zhuhai Rundu Pharmaceutical Co., Ltd. as the test preparation and gliclazide tablets (trade name: Glimicron®, specification: 40 mg) certified by Dainippon Sumitomo Pharma Co., Ltd. as the reference preparation. Secondary objective: To observe the safety of oral test preparation gliclazide tablets (specification: 40 mg) and reference preparation gliclazide tablets (trade name: Glimicron®, specification: 40 mg) in healthy subjects in China.

Start Date31 Oct 2024

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

CTIS2024-514298-23-00 / Not yet recruitingIIT

- S005190-213

Start Date02 Sep 2024

Sponsor / Collaborator-

CTRI/2024/07/071320 / Not yet recruitingNot Applicable

An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose, oral bioequivalence study of Dapagliflozin tablets 10 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500mg (T) Manufactured by Eris Lifesciences Ltd., India with Xigduo® XR 10 mg/ 500 mg (Dapagliflozin 10 mg and Metformin Hydrochloride Extended Release Tablets 500 mg) (R1) Manufactured by AstraZeneca Pharmaceuticals LP, USA and Imported & Marketed by AstraZeneca Pharma India Ltd., Bangalore, India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human male subjects under fasting condition. - NIL

Start Date02 Aug 2024

Sponsor / Collaborator

Eris Lifesciences Ltd.

100 Clinical Results associated with Gliclazide

100 Translational Medicine associated with Gliclazide

100 Patents (Medical) associated with Gliclazide

1,622

Literatures (Medical) associated with Gliclazide

01 Dec 2024·International Journal of Biological Macromolecules

Locust bean gum glutarate nanocomposite hydrogel microspheres of gliclazide: Optimization by Box-Behnken design and preclinical evaluation of anti-diabetic efficacy

Article

Author: Yadav, Harsh ; Maiti, Sabyasachi

In this study, carboxymethyl locust bean gum was synthesized and nanocomposite hydrogel microspheres (GHMs) of gliclazide were produced based on nanosilicate reinforcement and aluminium-ion driven gelation process, followed by covalent crosslinking with glutaric anhydride (GA). The effect of three independent variables (polymer and GA concentration, incubation time) on the drug entrapment efficiency (DEE%) and percent drug release at 8 h, was optimized using Box-Behnken design. The highest DEE (%) and lowest drug release was achieved at the following optimized conditions: polymer (2.43 %), GA (0.34 %), and incubation (27 min). The nanoscilicate-enriched matrix provided a maximum of 75.13 % DEE, 92.33 % gel fraction, and excellent flowability. The optimized microspheres had virtually spherical morphology, according to FE-SEM analysis. FTIR study indicated a hydrogen bonding interaction between the drug and other formulation components. X-ray and DSC measurements suggested that the crystallinity of the drug decreased following integration into the matrix. The optimized GHM demonstrated anomalous diffusion of gliclazide in simulated gastrointestinal fluids for 12 h without disintegration. In streptozotocin (50 mg/kg BW)-induced diabetic rats, the optimized formulation diminished blood glucose level by about 72 % in 12 h. Thus, the nanocomposite GHMs created by combining nanosilicate with GA had an outstanding potential for long-term control of diabetes.

01 Dec 2024·Diabetes, Obesity and Metabolism

Lipids and apolipoproteins and the risk of vascular disease and mortality outcomes in women and men with type 2 diabetes in the ADVANCE study

Article

Author: Hamet, Pavel ; Harrap, Stephen ; Mancia, Giuseppe ; Af Geijerstam, Peder ; Harris, Katie ; Woodward, Mark ; Chalmers, John ; Pikkemaat, Miriam ; Poulter, Neil ; Marre, Michel

AbstractAimWhether apolipoproteins (apolipoprotein A1, apolipoprotein B, apolipoprotein B/apolipoprotein A1 [ApoB/ApoA1] ratio) or very‐low‐density lipoprotein (VLDL) cholesterol are better risk predictors than established lipid risk markers, and whether there are sex differences, is uncertain, both in general populations and in patients with diabetes. The aim of this study was to assess the association between established risk markers, apolipoproteins and the risk of macro‐ and microvascular disease and death in a large study of women and men with diabetes and to assess the potential sex differences in the associations.Materials and MethodsEstablished lipid risk markers were studied in 11 140 individuals with type 2 diabetes from the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified‐Release Controlled Evaluation (ADVANCE) trial, and apolipoproteins (A1, B, ApoB/ApoA1 ratio) and VLDL cholesterol from nuclear magnetic resonance (NMR) lipid analyses in biobanked samples from 3586 individuals included in the ADVANCE case‐cohort study (ADVANCE CC). Primary outcomes were major macro‐ and microvascular events and death. Cox proportional hazards models adjusted for confounders were used to quantify the associations (hazard ratio [HR] and 95% confidence intervals [CIs]) between established lipid risk markers and apolipoproteins with study outcomes. To address potential effect modification by sex, we investigated the association between the lipid risk markers and outcomes in subgroup analyses by sex.ResultsThere was a lower risk of macrovascular complications for high‐density lipoprotein (HDL) cholesterol (HR [95%CI] 0.88 [0.82–0.95]), a higher risk for total cholesterol (1.10 [1.04–1.17]), low‐density lipoprotein (LDL) cholesterol (1.15 [1.08–1.22]), non‐HDL cholesterol (1.13 [1.07–1.20]) and the total cholesterol/HDL ratio (1.20 [1.14–1.27]) but no significant associations with triglycerides from ADVANCE. There was a higher risk of macrovascular complications for the ApoB/ApoA1 ratio (1.13 [1.03–1.24]) from the ADVANCE CC. Only the ApoB/ApoA1 ratio (1.19 [1.06–1.34]), but none of the established lipid risk markers, was associated with a higher risk of microvascular complications. There were no statistically significant sex differences for any of the established lipid risk markers or apolipoproteins with any outcome. Using C‐statistics and net reclassification improvement (NRI) did not detect significant improvement in predicting all outcomes by adding lipids or apolipoproteins to the models with confounding factors only.Conclusions/InterpretationAll established lipid risk markers, except triglycerides, were predictors of macrovascular complications, but not microvascular complications, in patients with type 2 diabetes. The ApoB/ApoA1 ratio was associated with major macro‐ and microvascular complications, but there was no evidence that apolipoproteins are better than established lipid risk markers in predicting cardiovascular complications in patients with type 2 diabetes.

01 Dec 2024·Journal of Hypertension

Combination blood pressure lowering therapy in patients with type 2 diabetes: messages from the ADVANCE trial

Review

Author: Harrap, Stephen ; Chalmers, John ; Poulter, Neil ; Mancia, Giuseppe ; Wang, Nelson ; Harris, Katie ; Woodward, Mark ; Marre, Michel ; Hamet, Pavel ; Grobbee, Diederick E.

The Action in Diabetes and Vascular disease: preterAx and diamicroN Controlled Evaluation (ADVANCE) trial investigated the effects of intensive blood pressure (BP) lowering using a fixed combination of perindopril-indapamide versus placebo in type 2 diabetes (T2D). The study showed that combination perindopril-indapamide had significant benefits in reducing cardiovascular, renal, and mortality events, with consistent relative risk reductions across different patient subgroups. Secondary analyses of ADVANCE have identified novel risk markers in T2D including cessation of BP lowering therapy, absent peripheral pulses and cardiac biomarkers to name a few. ADVANCE also shed light on practical aspects of hypertension management, including the limitations of office BP, tolerability of combination BP lowering therapy across the range of BP levels and the interpretation of changes in serum creatinine after treatment initiation. This review article summarizes the findings of ADVANCE and its subsequent substudies, which have been foundational in our understanding of BP management and the use of combination BP lowering therapy in T2D.

News (Medical) associated with Gliclazide

25 Apr 2023

·www.businesswire.com

VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA

TALLAHASSEE, Fla.--( BUSINESS WIRE )-- VySpine , a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System which is indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD). The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine's NanoVy-HA technology in partnership with Promimic AB. NanoVy-HA is a process in which the 3D printed UniVy OsteoVy-Ti implant is surface-treated with hydroxyapatite. Traditional coating is typically 50 micrometers, while NanoVy-HA surface treatment is a mere 20 nanometers thick. The NanoVy-HA technology is engineered to facilitate enhanced bone integration and quality to the entire surface of the UniVy OsteoVy-Ti implant. The NanoVy-HA coating penetrates the unique porous lattice structure of the UniVy OsteoVy-Ti implant. NanoVy-HA’s combination of high wettability and optimal surface chemistry, with optimized nano-roughness, mediates bioactivity and specific protein adsorption to the implant. These properties regulate cell behavior and influence tissue regeneration by increasing the osteoblast functions, building more bone faster. The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features optimal pore size and structure. It is offered in a vast array of footprints for nearly any cervical interbody approach. Additionally, it is available in a range of sizes, heights, and lordotic angles. About VySpine VySpine was created through active internal development and the licensing of various proven technologies using innovative materials and designs. This comprehensive line of core spine products and newly developed specialty products allow us to meet the needs of both health care providers and surgeons. The company strives to outpace the competition by collaborating with key spine innovators while providing a flexible, cost-effective approach to spine care. Learn more at vyspine.com About Promimic AB Promimic AB is a growth company that develops and markets biomaterials for improved osseointegration to leading companies in the fields of dental and orthopedic implants. The main product HAnano Surface has been developed from cutting edge research at Chalmers University of Technology in Sweden. The technology is proven to improve osseointegration in over 30 scientific studies and with over 900,000 implants in clinical use. Promimic has offices in Mölndal, Sweden and Austin, Texas, USA. For more information visit www.promimic.com “VySpine,” “UniVy OsteoVy-Ti” and “NanoVy” are registered trademarks of VySpine.

Drug Approval

19 Jul 2022

·healthtechinsider.com

New CGM Device for Type 2 Diabetes

MySugarWatch has pushed the pedal on an awareness campaign for its continuous non-invasive glucose monitor called sugarBEAT. MySugarWatch is the UK licensee of Nemaura Medical, a company specializing in developing wearable diagnostic devices. The company aims to cater to the awareness needs of the people with pre-diabetes and diabetes. The campaign, featured in the DailyMail, is set to reach about 1.2 million people. MySugarWatch aims to eliminate skin-pricks test strips historically used by patients to monitor blood sugar level for Type-2 diabetes patients. Studies show that 3.6 million in the UK suffer from Type-2 Diabetes while a further 12.3 million people are at risk of developing the disorder. MySugarWatch adds to the list of continuous glucose monitoring devices. It monitors your blood sugar level every 5 minutes, providing consistent data. The data is then stored in a dedicated app, which maps the 168 glucose level readings taken during the day. This allows you to identify trends and monitor Time-in-Range right from your phone. The device does require calibration with a finger stick; a reading each morning before eating is recommended. Continuous Glucose Monitoring (CGM) was difficult to achieve so far due to difficulties in procedure including regular needle insertion. CGMs like MySugarWatch that measure interstitial fluid glucose levels do not require a needle prick and easily allows patients to make lifestyle changes based on trends in their blood sugar level. These strategic changes will greatly help patients and healthcare professionals to manage, prevent and even reverse Type-2 pre-diabetes. MySugarWatch, unfortunately, is not for Type-1 diabetes patients, or patients who receive injectable insulin or who are taking sulfonylurea medications (Glibenclamide, Gliclazide, Glimepiride, Glipizide, Tolbutamide). As a result, it’s not completely useful as an “artificial pancreas” component. The product does have CE Mark clearance, but not FDA clearance yet.

26 Aug 2021

·endpts.com

BioDuro-Sundia plants its flag at former Par manufacturing site in CA

A former Par Pharma site in Irvine, CA, will now have a new tenant. BioDuro-Sundia will acquire a 40,000-square-foot oral solid dose manufacturing site in Irvine, the company announced Monday. The site will allow the company to scale up and cater to companies that need larger-scale production, Kent Payne, the president of development and manufacturing, said in a press release. The new site should be operational by the start of 2022. It will be able to produce 1 billion tablets and capsules a year, the company said. “BioDuro-Sundia is a pioneer in enhancing bioavailability, with 25 years of experience applying stabilized amorphous solid dispersion technology to poorly soluble drug product candidates,” he said. “Our clients have requested our support to provide commercial scale manufacturing to save time and maximize success, and it is a pleasure to take this next step with them.” BioDuro-Sundia is a CDMO with 2,000 employees in 10 sites across the country, including China and the US. The company specializes in small- and large-molecule discovery, IND submission support and the scaling of batches. It bills itself as a one-stop shop for its clients. The site is located at 72 Fairbanks in Irvine and was previously used by Par Pharmaceuticals. They acquired the site from Anchen Pharmaceuticals back in 2011, when they acquired the company. In 2020, BioDuro invested in a 150,000-square-foot R&D site in Wuxi City, China, and says that the integrated system can help save time and produce a better quality drug. In April, the company invested in adding a cGMP manufacturing site at the facility. That location handles oral dosage tablets and capsules. That added to its already-existing site in San Diego. Among the drugs manufactured by the company is Gliclazide, a sustained release tablet to treat diabetes from Tianjin Jun’an Bio. The drug is often used with metformin tablets, acarbose tablets or pioglitazone.

100 Deals associated with Gliclazide

External Link

KEGG	Wiki	ATC	Drug Bank
D01599	Gliclazide	A10BB09	DB01120

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	JP	Sumitomo Pharma Co., Ltd.	15 Feb 1984

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Preclinical	CN	Servier Tianjin Pharmaceutical Co. Ltd.	15 Aug 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASD2022	Not Applicable	Diabetes Mellitus, Type 2	23,016	Insulin	vwodopwgmx(rifpibooey) = zyphuetqcn ejkqulbvyt (mnxaflufce )	Positive	21 Sep 2022
				Sulphonylureas	vwodopwgmx(rifpibooey) = fqpylnjceq ejkqulbvyt (mnxaflufce )
ADA2020	Not Applicable	Diabetes Mellitus, Type 2 Second line	2,346	Gliclazide MR	(vbplutjjsg): HR = 1.28 (95% CI, 1.1 - 1.49) View more	Positive	01 Jun 2020
				Sitagliptin
NCT04132934 (DIA-RAMADAN, Pubmed \| Diabetes Res Clin Pract)	Not Applicable	Diabetes Mellitus, Type 2	1,244	Gliclazide modified release	(yrpfataztz) = mxhlkzxrkk mhzcyistql (bhqsejaptz ) View more	-	01 May 2020
NCT01679899 (Pubmed \| Diabetol Metab Syndr)	Phase 4	Diabetes Mellitus, Type 2	56	Gliclazide MR	wfsdtdyifp(qqkgskklgo) = fwgfsjwzsu tbbytppwyy (oemkwlibjp )	-	01 Jan 2017
NCT01709305 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	5,570	Sitagliptin+Glimepiride+Metformin (Phase 2: Metformin + Sitagliptin + Glimepiride)	kcweslvvic(wvzvsuskon) = ltdsqzphhg trnnwefbxp (ndtwqrxktz, hsrtfmseja - cbycjrydfj) View more	-	11 May 2016
				Repaglinide+Sitagliptin+Metformin (Phase 2: Metformin + Sitagliptin + Repaglinide)	kcweslvvic(wvzvsuskon) = thlsxeaehp trnnwefbxp (ndtwqrxktz, rwpohivblh - zgggftwdyu) View more
Pubmed \| Diabetes Metab Res Rev	Not Applicable	-	-	Insulin glargine plus gliclazide modified release combination therapy	(bpacdyrkzm) = zquuqdxfvy nwcwebtumd (bqmirvjknp )	Positive	01 Oct 2015
				Twice-daily premixed insulin monotherapy	(bpacdyrkzm) = iqssdfnquz nwcwebtumd (bqmirvjknp )
NCT01590771 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	498	Sitagliptin+Metformin+Glimepiride+Gliclazide (Sitagliptin)	xcnmptrgsw(mbslajfrns) = grtliqcuho zvzuzbqabm (wgervbzanf, tmvokwaugg - pajononrdq) View more	-	04 May 2015
				Placebo+Metformin+Glimepiride+Gliclazide (Placebo)	xcnmptrgsw(mbslajfrns) = yxppidzjhr zvzuzbqabm (wgervbzanf, khvgvaylti - aipnnlivde) View more
EASD2012	Not Applicable	Diabetes Mellitus, Type 2 \| Myocardial Ischemia	-	Glyburide	gsacpvroco(wwetulxbeb) = wyyipkfxmi qldsllxcxy (kulkcwpdpj, 1.08 - 1.33)	Positive	02 Oct 2012
				Gliclazide	gsacpvroco(wwetulxbeb) = miapcjhkll qldsllxcxy (kulkcwpdpj )

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