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  1. Colagiuri S, Matthews D, Leiter LA, Chan SP, Sesti G, Marre M
    Diabetes Res Clin Pract, 2018 Sep;143:1-14.
    PMID: 29802958 DOI: 10.1016/j.diabres.2018.05.028
    The sulfonylureas are effective oral glucose-lowering agents with a long history of clinical use. While all have the same general mechanism of action, their pharmacokinetic properties are influenced by factors such as dosage, rate of absorption, duration of action, route of elimination, tissue specificity, and binding affinity for pancreatic β-cell receptor. The result is a class of agents with similar HbA1c-lowering efficacy, but well-documented differences in terms of effects on hypoglycemia, and cardiovascular and renal safety. This review examines the differences between currently available sulfonylureas with a focus on how gliclazide modified release (MR) differs from other members of this class and from newer oral antihyperglycemic agents in the form of dipeptidyl peptidase-4 (DPP4) and sodium- glucose cotransporter 2 (SGLT2) inhibitors. The first part focuses on major outcome trials that have been conducted with the sulfonylureas and new oral agents. Consideration is then given to factors important for day-to-day prescribing including efficacy and durability, weight changes, hypoglycemia, renal effects and cost. Based on current evidence, third-generation sulfonylureas such as gliclazide MR possess many of the properties desired of a type 2 diabetes drug including high glucose-lowering efficacy, once-daily oral administration, few side effects other than mild hypoglycemia, and cardiovascular safety.
    Matched MeSH terms: Gliclazide/pharmacology; Gliclazide/therapeutic use*
  2. Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, et al.
    Diabetes Res Clin Pract, 2020 May;163:108154.
    PMID: 32330510 DOI: 10.1016/j.diabres.2020.108154
    AIMS: To explore the real-world safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan.

    METHODS: DIA-RAMADAN (NCT04132934) was a prospective, international, observational study conducted in nine countries. Patients >18 years of age with T2DM (N = 1244) were examined at an inclusion visit (V0) occurring 6-8 weeks before the start of Ramadan. Patients received a diary to report treatment changes, hypoglycaemic events (HEs), and other adverse events. Gliclazide MR was taken once daily for 14-18 weeks. A second visit (V1) was conducted 4-6 weeks after the end of Ramadan. The primary endpoint was the proportion of patients reporting ≥1 symptomatic HE. Changes in HbA1c, fasting plasma glucose (FPG), and body weight were secondary endpoints.

    RESULTS: The proportion of patients reporting ≥1 symptomatic HE during Ramadan was low (2.2%) with no reported severe HEs. There was a significant reduction in HbA1c (-0.3%), FPG (-9.7 mg/dL), body weight (-0.5 kg) and body mass index (-0.2 kg/m2) between V0 and V1 (p 

    Matched MeSH terms: Gliclazide/pharmacology; Gliclazide/therapeutic use*
  3. Panda BP, Krishnamoorthy R, Bhattamisra SK, Shivashekaregowda NKH, Seng LB, Patnaik S
    Sci Rep, 2019 11 22;9(1):17331.
    PMID: 31758056 DOI: 10.1038/s41598-019-53996-4
    Drug delivery and therapeutic challenges of gliclazide, a BCS class II drug used in type 2 diabetes mellitus (T2DM) can be overcome by exploring smarter carriers of second-generation nanocrystals (SGNCs). A combined method of emulsion diffusion, high-pressure homogenization and solvent evaporation method were employed in the preparation of gliclazide loaded poly (D, L-lactide-co-glycolide) (PLGA) SGNCs. Taguchi experimental design was adopted in fabrication of Gliclazide SGNc using Gliclazide -PLGA ratio at 1:0.5, 1:0.75, 1:1 with stabilizer (Poloxamer-188, PEG 4000, HPMC E15 at 0.5, 0.75, 1% w/v). The formulated gliclazide of SGNCs were investigated for physicochemical properties, in vitro drug release, and in vivo performance studies using type-2 diabetes rat model. The formulation (SGNCF1) with Drug: PLGA 1: 0.5 ratio with 0.5% w/v Poloxamer-188 produced optimized gliclazide SGNCs. SGNCF1 showed spherical shape, small particle size (106.3 ± 2.69 nm), good zeta potential (-18.2 ± 1.30 mV), small PDI (0.222 ± 0.104) and high entrapment efficiency (86.27 ± 0.222%). The solubility, dissolution rate and bioavailability of gliclazide SGNCs were significantly improved compared to pure gliclazide. The findings emphasize gliclazide SGNCs produce faster release initially, followed by delayed release with improved bioavailability, facilitate efficient delivery of gliclazide in T2DM with better therapeutic effect.
    Matched MeSH terms: Gliclazide/administration & dosage*; Gliclazide/pharmacokinetics; Gliclazide/chemistry
  4. Thalha AM, Mahadeva S, Boon Tan AT, Mun KS
    JGH Open, 2018 Oct;2(5):242-245.
    PMID: 30483596 DOI: 10.1002/jgh3.12083
    A 33-year-old man was referred with hyperosmotic symptoms of 4 weeks. Clinical examination showed palpable hepatomegaly and no stigmata of liver disease. Findings were random glucose 16.6 mmol/L, HbA1c 12.4%, triglyceride 6.2 mmol/L, normal LFTs and ultrasound liver: increased echogenicity. Management consisted of dietician referral and commencement of metformin 500 mg bd, diamicron MR 60 mg od, and fenofibrate 145 mg od. He was non-compliant, complaining of "heaviness of head" after consuming oral diabetic agents, without symptoms of hypoglycemia. Treatment was switched to Kombiglyze XR (saxaglipitin 5 mg + metformin 1000 mg) and empagliflozin 25 mg od. He presented 1 week later with generalised pruritus with ALT 307 IU/L and serum GGT 808 IU/L. Following this, a percutaneous liver biopsy was performed, revealing steatohepatitis and marked intra-hepatic cholestasis. Kombiglyze XR was withheld, with resolution of LFTs to baseline. Phenotypes of liver injury are categorised according to R value, defined as ratio ALT/ULN:ALP/ULN. R value of ≥5:hepatocellular injury, ≤2:cholestatic injury, 2-5:mixed-type injury. Here, R value points toward mixed type (R = 3.203). Hepatotoxicity in patients with NASH is difficult to diagnose, based on laboratory parameters. Liver histology was useful in indicating additional changes apart from NASH, causing liver derangement. The Rousal Uclaf Causality Assessment Method is a scoring method to determine the probability of drug induced liver injury. RUCAM score for this case was 6 (probable adverse drug reaction). Hepatotoxicity from saxagliptin not been reported prior. Clinicians need to be more vigilant, particularly in patients with NASH.
    Matched MeSH terms: Gliclazide
  5. Fouad Fadhil Al-Qaim, Md Pauzi Abdullah, Jalifah Latip, Wan Mohd Afiq Wan Mohd Khalik, Nurfaizah Abu Tahrim, Nurul Auni Zainal Abidin, et al.
    Sains Malaysiana, 2016;45:803-810.
    The big challenge for the detection of pharmaceutical residues in water samples is the type of ionization mode in
    terms of positive or negative ionization which plays an important role to identify and quantify the analytes using liquid
    chromatography/mass spectrometry. An analytical method was applied to analysis of gliclazide (diabetic drug) in surface
    water and wastewater from sewage treatment plants and hospitals. The proposed analytical method allows simultaneous
    isolation and concentration procedure using solid phase extraction (Oasis HLB) prior to separation using high-performance
    liquid chromatography. The detection and confirmation was achieved by applying time-of-flight analyzer. The limits of
    quantification were as low as 1.4 ng/L (deionized water), 4 ng/L (surface water), 27 ng/L (hospital influent), 10 ng/L
    (hospital effluent), 6 ng/L (sewage treatment plant effluent) and 21 ng/L (sewage treatment plant influent), respectively. On
    average, good recoveries of higher than 87% were obtained for gliclazide in the studied samples. The proposed method
    successfully determined and quantified gliclazide in surface water and wastewater. The results showed that gliclazide
    is a persistent compound in sewage treatment effluents as well as in the recipient rivers. Gliclazide was detected in all
    samples and the highest concentration was 130 ng/L in influent of sewage treatment plant.
    Matched MeSH terms: Gliclazide
  6. Lim PC, Lim SL, Oiyammaal C
    Med J Malaysia, 2012 Feb;67(1):21-4.
    PMID: 22582544
    Type-2 diabetes mellitus (T2DM) patients who were on gliclazide co-administered with metformin were changed to pre-combined glibenclamide-metformin tablets in the Endocrine Clinic, Penang Hospital. We conducted a retrospective study to evaluate the differences in glycaemic control and treatment cost following the change. Eighty patients (60% females) with a mean age of 55 years old were studied. Mean glycosylated haemoglobin (HbAlc) reduction was -0.92% (p<0.01) and -0.83% (p<0.01) after three and six months respectively. Patients with baseline HbA1c > or =8% had greater reduction in mean HbA1c (-1.36%) after six months. The treatment cost per month was reduced by 45% at 3 months (p<0.01)) and 44% at 6 months (p<0.01). The change to pre-combined glibenclamide-metformin tablets resulted in significant improvement in glycaemia and reduction in treatment cost.
    Matched MeSH terms: Gliclazide/administration & dosage*
  7. Chan SP, Colagiuri S
    Diabetes Res Clin Pract, 2015 Oct;110(1):75-81.
    PMID: 26361859 DOI: 10.1016/j.diabres.2015.07.002
    AIMS: Sulfonylureas are well positioned in treating type 2 diabetes, after lifestyle modification and metformin. The sulfonylurea gliclazide was given preference over glibenclamide in older people with type 2 diabetes in the World Health Organization model list of essential medicines. Consequently, a systematic review and meta-analysis of randomized controlled trials of the efficacy and safety of gliclazide versus other oral insulinotropic agents (sulfonylureas, dipeptidyl peptidase-4 inhibitors, and glinides) was performed.

    METHODS: Two reviewers searched MEDLINE for studies of ≥12 weeks duration in adults with type 2 diabetes. The key search word was "gliclazide", filtered with "randomized controlled trial", "human" and "19+ years". Differences were explored in mean change in glycated hemoglobin (HbA(1c)) from baseline (primary outcome) and risk of hypoglycemia (secondary outcome) between gliclazide and other oral insulinotropic agents; and other sulfonylureas.

    RESULTS: Nine out of 181 references reported primary outcomes, of which 7 reported secondary outcomes. Gliclazide lowered HbA1c more than other oral insulinotropic agents, with a weighted mean difference of -0.11% (95%, CI -0.19 to -0.03%, P=0.008, I(2)=60%), though not more than other sulfonylureas (-0.12%; 95%, CI -0.25 to 0.01%, P=0.07, I(2)=77%). Risk of hypoglycemia with gliclazide was not different to other insulinotropic agents (RR 0.85; 95%, CI 0.66 to 1.09, P=0.20, I(2)=61%) but significantly lower than other sulfonylureas (RR 0.47; 95%, CI 0.27 to 0.79, P=0.004, I(2)=0%).

    CONCLUSION: Compared with other oral insulinotropic agents, gliclazide significantly reduced HbA1c with no difference regarding hypoglycemia risk. Compared with other sulfonylureas, HbA1c reduction with gliclazide was not significantly different, but hypoglycemia risk was significantly lower.

    Matched MeSH terms: Gliclazide/adverse effects; Gliclazide/therapeutic use*
  8. Ahmad Rashidi Mohamed Tahir, Nurasmaa Agussaiful, Shairyzah Ahmad Hisham, Aneesa Abdul Rashid, Ahmad Yusuf Yahaya, Navin Kumar Devaraj
    MyJurnal
    Introduction: Since 1978, Rohingya refugees have fled from their native nation, Myanmar to escape ethnic prose- cution. They comprise of the Muslim minority ethnic group originating from the Rakhine state in Myanmar. In many host countries, they may have difficulty to access health care services. The Islamic Association of Malaysia (IMAM) Response and Relief Team (IMARET) have taken many initiatives to provide healthcare services to the refugees through their volunteer-led mobile clinics. Therefore, this study aims to evaluate the utilisation of drugs among type 2 diabetes mellitus (T2DM) patients visiting this clinic. Methods: This was a cross-sectional study among Rohingya refugees with T2DM that visited the IMARET mobile clinics from August until November 2017. Convenient sampling method was used. Data were collected through patient’s interview, review of the patient’s prescriptions and their HbA1c readings. Results: A total of 29 T2DM patients were included in this study. The majority were female (75.9%) and aged below 65 years old (75.9%). The most commonly prescribed anti-diabetic agent was metformin (72.2%), followed by glibenclamide (22.2%) and gliclazide (5.6%). Metformin as a monotherapy (31%) was the most frequent treatment prescribed. More patients had controlled T2DM (62.1%) compared to those with uncontrolled DM. We found 90.9% of patients who were treated according to the recommended DM guidelines achieved a good blood glucose control (p=0.02). Conclusion: In Rohingya refugees having T2DM who were treated in the IMARET mobile clinic, the percentage having good control DM status is higher in those whose treatment regimen adheres to the clinical practice guidelines.
    Matched MeSH terms: Gliclazide
  9. Krishnamoorthy R., Bibhu Prasad Panda, Shivashekaregowda N. K. H., Low B. S., Bhattamisra S. K.
    MyJurnal
    Introduction: Second generation functionalized nanocrystal is the advancement of nanocrystal technology with great potential to accommodate BCS (Biopharmaceutical Classification System) class II drugs to meet their formulation and drug delivery challenges. Gliclazide is a BCS class II drug used in the treatment of type 2 diabetes, shows poor water solubility and low rate of dissolution, leads to poor and variable oral bioavailability. The second generation poly(D,L-lactide-co-glycolide) (PLGA) Hydroxypropyl methylcellulose (HPMC) based functionalized nanocrystals of gliclazide were prepared by a combination method of emulsion diffusion-high pressure homogenization-solvent evaporation. Methods: Gliclazide second generation nanocrystals were fabricated with taguchi orthogonal experimental design in combination of step up and top down nanoformulation strategies using drug-polymer (PLGA) ratio at 1:0.5, 1:0.75, 1:1 with HPMC(0.5, 0.75, 1% w/v) as stabilizer. The formulated gliclazide PLGA-HPMC nanocrystals were investigated on particle size, polydispersity index, zeta potential, solubility study, drug entrapment efficiency, in vitro drug release, and surface morphology and compatibility studies. The gliclazide PLGA nanocrystals formulation was prepared with Drug : PLGA at 1: 1 ratio with concentrations 0.75% w/v HPMC at 5 homogenization cycles with 1000bar produce optimized gliclazide nanocrystals. Results: The optimized MSGNC8 formulation
    showed particle size of 239.9 nm, entrapment efficiency 98.62%, and drug release of 43.75%, 82.12% and 98.08% at 3hrs, 24hrs, and 48hrs compared to pure gliclazide % drug release of 28.73%, 67.51% and 78.41% at 3hrs, 24hrs, 48hrs respectively. The solubility study of optimized formulation shows eight folds increased in saturation solubility compared to pure drug. Scanning electron microscopy (SEM) analysis of the gliclazide nanocrystals revealed that
    gliclazide retained its crystal morphology in polymeric nanocrystals. Further, fourier-transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) studies on gliclazide PLGA-HPMC nanocrystals emphasize drug and excipient compatibility in development of gliclazide nanocrystals. Conclusion: The potential outcomes of research findings emphasize that the developed gliclazide second-generation nanocrystals, which resulted in increase in drug solubility and rate of dissolution with delayed modified release, can be explored in delivery of gliclazide for type 2 diabetes management.
    Matched MeSH terms: Gliclazide
  10. Hassanein M, Al Sifri S, Shaikh S, Raza SA, Akram J, Rudijanto A, et al.
    Diabetes Ther, 2021 Jun;12(6):1703-1719.
    PMID: 33974216 DOI: 10.1007/s13300-021-01067-1
    INTRODUCTION: To analyse the safety and effectiveness of gliclazide modified release (MR) in adults with type 2 diabetes mellitus participating in Ramadan from three geographically and culturally different regions of the world included in the DIA-RAMADAN study.

    METHODS: DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6-8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4-6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events.

    RESULTS: Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA1c and fasting plasma glucose.

    CONCLUSION: These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN.

    TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.

    Matched MeSH terms: Gliclazide
  11. Low, Qin Jian, Chew, Soo Foong
    MyJurnal
    Both metformin and gliclazide have been used extensively in the management of type II diabetes mellitus. Metformin and gliclazide overdose can lead to severe hypoglycaemia refractory to intravenous (IV) dextrose rescue therapy. A 21-year-old man complained of vomiting and felt dizzy after four hours of taking 70 tablets of Metformin 500 mg and 40 tablets of Gliclazide 80 mg. He had major depressive disorder and wanted to commit suicide. He was given IV Dextrose 50% 50 cc immediately. Octreotide had been used successfully to reverse the refractory hypoglycaemia caused by gliclazide overdose. Unfortunately, he developed severe lactic acidosis with acute kidney injury. Dialysis had been done by continuous venovenous haemodiafiltrationa and intravenous sodium bicarbonate 8.4% infusion was given. However, the patient succumbed due to the severe lactic acidosis and kidney failure despite of urgent dialysis. Octreotide infusion helps in preventing refractory hypoglycaemia secondary to sulfonylurea overdose by inhibit calcium-mediated insulin release. Metformin overdose causes severe lactic acidosis due to conversion of glucose to lactate. Sodium bicarbonate therapy in metformin induced lactic acidosis is also controversial. Though sulfonylurea and metformin are the most commonly-prescribed anti-hypoglycaemic agents, thus during prescribing everyone has to be careful about the overdoses and side effects of these drugs.
    Matched MeSH terms: Gliclazide
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