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Drugs and Drug Delivery for Diabetes Mellitus Treatment

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A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Targeting and Design".

Deadline for manuscript submissions: closed (10 May 2023) | Viewed by 14447

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Prof. Dr. Laurent Kodjikian

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Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, University of Lyon 1, 69004 Lyon, France
Interests: retina; DME; AMD; uveitis; steroids; anti-VEGF
Special Issues, Collections and Topics in MDPI journals

Dr. Thibaud Mathis

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Guest Editor

Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, University of Lyon 1, 69004 Lyon, France
Interests: retina; DME; AMD; oncology; steroids; anti-VEGF
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Diabetes is an epidemic disease with a prevalence that will double over the next 20 years. Diabetic macular oedema is the main cause of visual impairment in young people under 50. Screening for diabetic retinopathy is essential and is increasingly helped by artificial intelligence. The classification of diabetic retinopathy is now quite old and must evolve, particularly with the help of OCT. Diagnosis has become multimodal. As for treatments, they are numerous, from anti-VEGF to steroids, with short- or long-acting molecules. These products are being handled better and better, and experience with them is growing. The results of observational studies sometimes differ a little or a lot from randomized controlled studies. Observational real-life studies are therefore becoming increasingly important in the medical world because they are relevant to our daily clinical practice. New treatments are also being considered.

I therefore wanted a Special Issue of the famous Pharmaceutics journal to be quite open about the ophthalmological damage of diabetes, from diabetic retinopathy to diabetic macular oedema, more specifically dedicated to its therapeutic management. Indeed, I would like to receive original articles about new molecules with new drug molecular structures, new pathways of action, new mechanisms of action, new combination therapies or even biosimilars. Articles on short, medium or long delivery systems, such as implants, are welcome, especially on steroids, which are classical in DME management.

Prof. Dr. Laurent Kodjikian
Dr. Thibaud Mathis
Guest Editors

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Keywords

diabetes
diabetic macular edema (DME)
diabetic retinopathy
Anti-VEGF to steroids
molecular structures
drug development
drug targeting
combination therapies
delivery system
implants

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Drugs and Drug Delivery for Diabetes Mellitus Treatment, 2nd Edition in Pharmaceutics

Published Papers (9 papers)

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10 pages, 1010 KiB

Open AccessArticle

Relevance of Visual Acuity Measurement for Therapeutic Decisions in Diabetic Macular Edema

by Thibaud Mathis, Batoul El Ameen, Cristina Vartin, Yasmine Serrar, Frédéric Matonti, Aditya Sudhalkar, Alper Bilgic, Amina Rezkallah and Laurent Kodjikian

Pharmaceutics 2023, 15(6), 1607; https://doi.org/10.3390/pharmaceutics15061607 - 29 May 2023

Viewed by 815

Abstract

This study aimed to determine the validity of basing retreatment decisions on anatomical criteria alone (captured using optical coherence tomography (OCT)—OCT-guided strategy) rather than the gold standard (combined visual acuity (VA) and OCT) in patients with diabetic macular edema (DME). This cross-sectional study included 81 eyes undergoing treatment for DME from September 2021 to December 2021. An initial therapeutic treatment decision based on OCT results was made on inclusion. Subsequently, in light of the patient’s VA score, this initial decision was upheld or adjusted, and the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. In 67 out of the 81 eyes included in the study (82.7%), the OCT-guided strategy produced equivalent results to the gold standard. In this study, the OCT-guided retreatment decision strategy yielded sensitivity and specificity of 92.3% and 73.8%, respectively, and PPV and NPV of 76.6% and 91.2%, respectively. These findings differed according to the patient’s treatment regimen: the sensitivity and specificity for eyes under a treat and extend regimen was higher, 100% and 88.9%, respectively, than eyes under a Pro Re Nata regimen, 90% and 69.7%, respectively. These findings show that VA testing could be omitted from the follow-up of certain patients with DME treated with intravitreal injections without impacting the quality of care. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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18 pages, 6556 KiB

Open AccessArticle

The Oral Delivery System of Modified GLP-1 by Probiotics for T2DM

by Qing Wang, Haixin Guo, Wenwei Mao, Xiuping Qian and Yangang Liu

Pharmaceutics 2023, 15(4), 1202; https://doi.org/10.3390/pharmaceutics15041202 - 10 Apr 2023

Viewed by 1896

Abstract

The glucagon-like peptide-1 (GLP-1) is a peptide with incretin activity and plays an important role in glycemic control as well as the improvement of insulin resistance in type 2 diabetes mellitus (T2DM). However, the short half-life of the native GLP-1 in circulation poses difficulties for clinical practice. To improve the proteolytic stability and delivery properties of GLP-1, a protease-resistant modified GLP-1 (mGLP-1) was constructed with added arginine to ensure the structural integrity of the released mGLP-1 in vivo. The model probiotic Lactobacillus plantarum WCFS1 was chosen as the oral delivery vehicle with controllable endogenous genetic tools driven for mGLP-1 secretory constitutive expression. The feasibility of our design was explored in db/db mice which showed an improvement in diabetic symptoms related to decreased pancreatic glucagon, elevated pancreatic β-cell proportion, and increased insulin sensitivity. In conclusion, this study provides a novel strategy for the oral delivery of mGLP-1 and further probiotic transformation. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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13 pages, 870 KiB

Open AccessArticle

Focal Photocoagulation as an Adjunctive Therapy to Reduce the Burden of Intravitreal Injections in Macula Edema Patients, the LyoMAC2 Study

by Lucas Séjournet, Laurent Kodjikian, Sandra Elbany, Benoit Allignet, Emilie Agard, Mayeul Chaperon, Jérémy Billant, Philippe Denis, Thibaud Mathis, Carole Burillon and Corinne Dot

Pharmaceutics 2023, 15(2), 308; https://doi.org/10.3390/pharmaceutics15020308 - 17 Jan 2023

Cited by 2 | Viewed by 1183

Abstract

Aim: To assess the efficacy of focal photocoagulation of capillary macroaneurysms (CMA) to reduce the burden of intravitreal injections (IVI) in patients with macular edema (ME). Materials and Methods: Retrospective multicenter study in patients with diabetic ME or ME secondary to retinal vein occlusion (ME-RVO). CMA associated with ME were selectively photocoagulated. Patients were followed for one year after photocoagulation. Results: 93 eyes of 76 patients were included in this study. At 6 months after the laser (n = 93), there was a significant decrease in mean macular thickness (from 354 µm to 314 µm, p < 0.001) and in mean IVI number (from 2.52 to 1.52 at 6 months, p < 0.001). The mean BCVA remained stable (0.32 and 0.31 logMAR at baseline and 6 months, p = 0.95). At 12 months (n = 81/93), there was a significant decrease in mean macular thickness (from 354 µm to 314 µm, p < 0.001) and in mean IVI number (from 4.44 to 2.95 at 12 months, p < 0.001), while the mean BCVA remained stable (0.32 and 0.30 logMAR at baseline and 12 months, p = 0.16). Conclusion: Focal laser photocoagulation of CMA seems to be effective and safe for reducing the burden of IVI in patients with ME. Their screening during the follow-up should be considered closely. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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14 pages, 180716 KiB

Open AccessArticle

9-N-n-alkyl Berberine Derivatives: Hypoglycemic Activity Evaluation

by Mikhail V. Khvostov, Elizaveta D. Gladkova, Sergey A. Borisov, Marina S. Fedotova, Nataliya A. Zhukova, Mariya K. Marenina, Yulia V. Meshkova, Nicolae Valutsa, Olga A. Luzina, Tatiana G. Tolstikova and Nariman F. Salakhutdinov

Pharmaceutics 2023, 15(1), 44; https://doi.org/10.3390/pharmaceutics15010044 - 22 Dec 2022

Cited by 1 | Viewed by 1373

Abstract

Several novel 9-N-n-alkyl derivatives of berberine (C5, C7, C10, C12) were synthesized. They were analyzed in vitro and in vivo for their hypoglycemic activity. In vitro studies showed that the derivatives with shorter alkyl substitutes at concentrations ranging from 2.5 to 10 μM were able to stimulate glucose consumption by HepG2 cells more prominently than the derivatives with longer substitutes (C10 and C12). All compounds demonstrated a better effect compared to berberine. Their impact on cells’ viability also depended on the alkyl substitutes length, but in this case, C10 and C12 derivatives demonstrated the best results. A similar correlation was also found in the OGTT, where the C5 derivative demonstrated a pronounced hypoglycemic effect at a dose of 15 mg/kg and C12 was less effective. This compound was further investigated in C57BL/6^Ay mice for four weeks and was administered at a dose of 15 mg/kg. Pronounced effect of C12 on carbohydrate metabolism in mice was discovered: there was a decrease in fasting glucose levels and an increase in glucose tolerance in OGTT on the 14th and 28th days of the experiment. However, at the end of the experiment, signs of hepatosis exacerbation and an increase in the content of hepatic aminotransferases in blood were found. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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16 pages, 2158 KiB

Open AccessArticle

Management of Patients with Diabetic Macular Edema Switched from Dexamethasone Intravitreal Implant to Fluocinolone Acetonide Intravitreal Implant

by Stéphanie Baillif, Pascal Staccini, Michel Weber, Marie-Noëlle Delyfer, Yannick Le Mer, Vincent Gualino, Laurence Collot, Pierre-Yves Merite, Catherine Creuzot-Garcher, Laurent Kodjikian and Pascale Massin

Pharmaceutics 2022, 14(11), 2391; https://doi.org/10.3390/pharmaceutics14112391 - 05 Nov 2022

Cited by 7 | Viewed by 1277

Abstract

To assess anatomical and functional outcomes after switching from dexamethasone implant (DEXi) to fluocinolone acetonide implant (FAci) in 113 diabetic macular edema eyes, a multicentric retrospective observational study was conducted. Seventy-five eyes (73.5%) were switched 1–8 weeks after their last DEXi. The mean best-corrected visual acuity improved to 59.8 letters at month 4 and remained stable during the follow-up. The mean central macular thickness (CMT) significantly decreased during the follow-up, with a minimum of 320.9 μm at month 3. The baseline CMT was higher in eyes that received the last DEXi >8 weeks versus <8 weeks before the first FAci (p < 0.021). After FAci injection, additional treatments were needed in 37 (32.7%) eyes. A longer diabetes duration (p = 0.009), a longer time between the last DEXi and the first FAci (p = 0.035), and a high baseline CMT (p = 0.003) were risk factors for additional treatments. The mean intraocular pressure was <19 mmHg at all timepoints, with no difference between eyes receiving the last DEXi ≤8 weeks or >8 weeks before the switch. Switching from DEXi to FAci in DME is effective and safe. A short time between the last DEXi and the first FAci reduced CMT fluctuations and the need for early additional treatments. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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15 pages, 2217 KiB

Open AccessArticle

Epidemiology of Treated Diabetes Ocular Complications in France 2008–2018—The LANDSCAPE French Nationwide Study

by Catherine Creuzot-Garcher, Pascale Massin, Mayer Srour, Florian Baudin, Corinne Dot, Sylvia Nghiem-Buffet, Jean-Francois Girmens, Cedric Collin, Anne Ponthieux and Cecile Delcourt

Pharmaceutics 2022, 14(11), 2330; https://doi.org/10.3390/pharmaceutics14112330 - 28 Oct 2022

Cited by 5 | Viewed by 1367

Abstract

Aim: LANDSCAPE aimed to estimate the annual incidence and prevalence of treated diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) between 2008 and 2018. Methods: This French nationwide observational study used data from the French National Health Insurance Databases covering 99% of the French population. Data about healthcare consumption were used to identify adults treated with anti-VEGFs or dexamethasone implants (for DME) and with pan-retinal photocoagulation (for PDR). All French patients newly treated between 2008 and 2018 were included. Incidence and prevalence of treated DME and PDR were estimated for the age-matched general population and the population with diabetes in France. Sociodemographic characteristics and medical history were described in both populations. Results: We identified 53,584 treated DME patients and 127,273 treated PDR patients between 2008 and 2018, and 11,901 DME and 11,996 PDR new incident patients in 2018. The treated DME incidence in 2018 was 2.5 per 10,000 in the general population and 37.3 per 10,000 in the population with diabetes. Prevalence in 2018 was 9.5 and 143.7 per 10,000 in the respective populations. Treated PDR incidence in 2018 was 2.3 per 10,000 in the general population and 31.2 per 10,000 in the population with diabetes. Prevalence in 2018 was 19.9 and 270.3 per 10,000 in the respective populations. Incidence and prevalence were not age-dependent. Incidence of treated PDR incidence was relatively stable from 2008–2018. Incidence of treated DME incidence rose from 2012–2018, probably due to widening access to newly available treatments, such as anti-VEGFs. Conclusions: We provide exhaustive nationwide data on the incidence and prevalence of treated diabetic ocular complications in France over a 10-year period. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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9 pages, 1147 KiB

Open AccessArticle

Intra-Ocular Pressure Response to Dexamethasone Implant Injections in Patients with a History of Filtering Surgery: The TRABEX Study

by Amina Rezkallah, Laurent Kodjikian, Aymeric Barbarroux, Corentin Laventure, Antoine Motreff, Samuel Chacun, Frédéric Matonti, Philippe Denis and Thibaud Mathis

Pharmaceutics 2022, 14(9), 1756; https://doi.org/10.3390/pharmaceutics14091756 - 23 Aug 2022

Cited by 5 | Viewed by 1049

Abstract

Patients with both macular edemas, of various etiologies such as diabetes and glaucoma, may suffer serious loss of vision if either disease goes untreated. Where no effective alternative therapies are available, dexamethasone implant (DEX-I) injections may be the only choice of treatment, despite the risk of a possible increase in intraocular pressure (IOP) when using steroids. Although many studies have reported on IOP evolution in eyes treated with DEX-I, little is known specifically about eyes with a history of filtering surgery. The aim of this observational series was to evaluate the IOP response following DEX-I injection in eyes presenting conventional filtering surgeries or microinvasive glaucoma surgeries (MIGS). Twenty-five eyes were included in this study. A total of 64% of the eyes did not experience OHT during follow-up. Additional IOP-lowering therapy was needed for 32% of eyes, and 20% of eyes (all showing bleb fibrosis) required further filtering surgery: 50% of eyes in the MIGS group and 10.5% of eyes in the conventional filtering surgery group. A significant positive correlation was found between IOP at baseline and the maximum IOP throughout follow-ups after DEX-I (r = 0.45, p = 0.02). In conclusion, if DEX-I is used when there are no alternative therapies for treating macular edema, IOP in eyes with a history of filtering surgery is generally manageable. Those eyes which previously underwent conventional therapy with effective blebs obtained better IOP control after DEX-I injections and mostly did not require any additional IOP-lowering therapy or surgery. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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14 pages, 849 KiB

Open AccessArticle

Dose–Response Association of Metformin with Parkinson’s Disease Odds in Type 2 Diabetes Mellitus

by Kuang-Hua Huang, Ya-Lan Chang, Shuo-Yan Gau, Tung-Han Tsai and Chien-Ying Lee

Pharmaceutics 2022, 14(5), 946; https://doi.org/10.3390/pharmaceutics14050946 - 27 Apr 2022

Cited by 10 | Viewed by 2037

Abstract

Background. Studies have demonstrated that patients with diabetes mellitus who receive metformin have a lower risk of developing Parkinson’s disease (PD). However, studies have also suggested that metformin may increase the risk of PD. In this study, we investigated whether metformin use was associated with the risk of PD in type 2 diabetes mellitus (T2DM). Methods. In this population-based cross-sectional study, patients with T2DM diagnosed between 2001 and 2018 were enrolled. We categorized these patients as metformin users or nonusers. Participants below 50 years old were excluded. Two models were employed to evaluate the associations of metformin exposure and use intensity with PD after 3 and 5 years of follow-up. Results. Patients with T2DM who received <300 cumulative defined daily doses (cDDD) of metformin and those with metformin use intensity of <10 DDD/month had respective odds ratios (ORs) for PD of 0.88 (95% confidence interval [CI] = 0.83–0.94) and 0.87 (95% CI = 0.81–0.93) in a 3-year follow-up. In a 5-year follow-up, such patients had respective ORs for PD of 0.94 (95% CI = 0.90–0.98) and 0.93 (95% CI = 0.89–0.98). Patients with T2DM who received ≥300 cDDD of metformin or used metformin with intensity of ≥10 DDD/month experienced no neuroprotective effects after 3 or 5 years. Conclusions. Metformin was associated with PD odds in T2DM in a dose–response association manner. Patients who received low dosage and intensity of metformin use were associated with lower odds of PD, while higher dosage and intensity of metformin use had no neuroprotective effect. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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Review

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15 pages, 624 KiB

Open AccessReview

Current Treatments and Innovations in Diabetic Retinopathy and Diabetic Macular Edema

by Jesus H. Gonzalez-Cortes, Victor A. Martinez-Pacheco, Jesus E. Gonzalez-Cantu, Alper Bilgic, Francesc March de Ribot, Aditya Sudhalkar, Jesus Mohamed-Hamsho, Laurent Kodjikian and Thibaud Mathis

Pharmaceutics 2023, 15(1), 122; https://doi.org/10.3390/pharmaceutics15010122 - 29 Dec 2022

Cited by 9 | Viewed by 2620

Abstract

Diabetic retinopathy (DR) is one of the leading causes of blindness worldwide. Multiple treatment options have been used over time to attempt to modify the natural progression of the disease in both proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME). These two retinal complications are the result of microvascular occlusions and vascular hyperpermeability and are considered one of the leading causes of irreversible blindness in patients of working age. It is now well demonstrated that PDR and DME are associated with increased levels of inflammatory and pro-angiogenic factors in the ocular compartment. To date, laser photocoagulation, vascular endothelial growth factor (VEGF) inhibitors, and corticosteroids have demonstrated efficacy in their treatment in large randomized controlled trials and in real-life observational studies. This manuscript aims to provide a comprehensive review of current treatments, including the main drugs used in diabetic pathologic manifestations, as well as new therapeutic alternatives, such as extended-release intraocular devices. Full article

(This article belongs to the Special Issue Drugs and Drug Delivery for Diabetes Mellitus Treatment)

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