In-vitro and in-vivo performance of locally manufactured glimepiride tablet generics compared to the innovator (Amaryl®) tablets.

Both physicians and patients in Egypt often express concern as to the clinical efficacy of locally manufactured glimepiride tablet generics whenever adequate control of blood sugar is not achieved with these products. The present study addresses this issue. The pharmaceutical quality of four glimepiride 3 mg tablet generics purchased in Egypt from local pharmacies was assessed relative to the innovator product (Amaryl®), 3 mg tablets. Uniformity of Content, dissolution rate, disintegration time and hardness were determined. Products were subjected to a 6-month stability study under stress condition (40 °c/75%RH). The same brands were evaluated in vivo in a clinical study conducted in the Main Alexandria University Hospital involving 100 patients (20 patients per brand including innovator). Patients recruited were newly diagnosed type II diabetics. Glimepiride tablets were used as a monotherapy. Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1C) were measured over a period of 3 months. The results indicated differences (p ≤ .05) in the in vitro and in vivo performance of the tested products; innovator and tested generics substitution was not evident. The stability study indicated that the tablets were prone to deterioration in their physical characteristics, particularly dissolution profiles, upon storage of blisters in a hot humid climate. In vitro/in vivo correlations were investigated seeking to identify an in vitro test to serve as a performance indicator for glimepiride tablets in the post-marketing period. The similarity factor (f2) of the dissolution data proved to be a good indicator of in vivo performance of the tablets.

Prognostic Value of Hyperglycemia and Insulin Resistance Among Patients with Confirmed COVID-19 Infections at Admission to the Alexandria Fever Hospital, Egypt.

Background: The interaction between COVID-19 infection, hyperglycemia, and insulin resistance (IR) may lead to poor outcome. Methods: This prospective study included 100 adult participants without diabetes attending Alexandria Fever Hospital with confirmed COVID-19 infections. They were classified into four groups according to disease severity using World Health Organization (WHO) criteria. Demographic and clinical parameters were collected. Laboratory investigations were obtained. Another follow-up fasting plasma glucose (FPG) value was measured after 3 months in cured patients. Results: Admission FPG, follow-up FPG, lipid profile, markers of IR, and inflammation were significantly higher in severe and critical cases than in mild and moderate cases with increasing values with increased severity. Furthermore, these parameters were significantly higher in died cases compared with cured cases. Admission FPG, TyG index, and homeostatic model assessment (HOMA)-IR showed significant positive correlations with follow-up FPG. Admission FPG was the only independent mortality predictor in multivariate analysis (P = 0.027) with 1.7-folds increased mortality risk with each 10 mg/dL increments. Values exceeding 117 mg/dL, 2.2, and 6.33 for admission FPG, HOMA-IR, and Fasting Insulin Resistance Index, respectively, were able to predict mortality in the studied sample. Conclusions: These results will help in identifying patients at high risk of severe infection and death at admission and take early actions to improve outcome.

Association of diabetic foot ulcers with chronic vascular diabetic complications in patients with type 2 diabetes.

CONTEXT: Diabetes mellitus is a common disease which is prevalent globally, presenting with chronic complications and constitutes a major risk to the patient. Diabetic foot ulcers are the single biggest risk factor for non-traumatic lower limb amputations in persons with diabetes. We aimed to screen for the chronic vascular diabetic complications in patients with diabetic foot ulcers (DFUs) and to assess the association of diabetic foot ulcers with these complications in the study group. SUBJECTS AND METHODS: This cross-sectional study included 180 type 2 diabetic patients (aged 30-70 years) with diabetic foot ulcers who attended the Outpatient Clinic of Diabetes in Alexandria Main University Hospital. Full diabetic foot examination was done to all study subjects. DFUs were assessed using University of Texas Diabetic Wound Classification System. HbA1c, LDL-C, serum creatinine, and urinary albumin creatinine ratio (ACR) were measured for all study subjects. Estimated glomerular filtration rate (eGFR) was calculated using CKD-EPI equation. Fundus examination was done for all study subjects. RESULTS: The prevalence of diabetic kidney disease (DKD) and diabetic retinopathy (DR) was 86.1% and 90% respectively among the study group. 86.7% of patients had neuropathic DFUs, 11.1% of them had ischemic DFUs and 2.2% had neuro-ischemic DFUs. Regarding diabetic peripheral neuropathy (DPN) and peripheral arterial disease (PAD) as risk factors for developing DFU, the prevalence of both of them respectively was 82% and 20% among the study group. There was statistically significant association between both DKD, DR and peripheral neuropathy. There was also statistically significant association between both DKD, DR and peripheral arterial disease (PAD). CONCLUSION: Chronic vascular diabetic complications are common among type 2 diabetic patients with diabetic foot ulcers. There is statistically significant association between these complications and diabetic peripheral neuropathy (DPN) and peripheral arterial disease (PAD).

Diabetic hypoglycaemia during Ramadan fasting: A trans-national observational real-world study.

OBJECTIVES: To describe the risk of hypoglycaemia during Ramadan and determine its risk factors, and the impact of hypoglycaemia on patients' behaviour. METHODS: A cross-sectional multi-country observational study, with data captured within 6 weeks after Ramadan 2015. Patients' and disease characteristics and its management, the risk of hypoglycaemia and patients' response to hypoglycaemia were recorded. RESULTS: A cohort of 1759 patients; majority with type 2 diabetes mellitus from North Africa, Arabian Gulf, Saudi Arabia, and the Indian subcontinent. Hypoglycaemia was reported by 290 patients (16.8%); particularly affecting type 1 diabetes patients and in insulin-treated patients in general. Age was significantly younger in the hypoglycaemia group (P < 0.001). The commonest responses were reducing the dose or frequency of medications (42%), attending primary care providers (24.5%) or increasing monitoring (20.7%). Fasting was interrupted by 67% only of those who experienced hypoglycaemia and recourse to emergency services was pursued by less than a quarter of patients with hypoglycaemia. The country-wise analysis of the rates of hypoglycaemia was greatest in Egypt (51.3%) and lowest in Pakistan (3.5%). CONCLUSIONS: Hypoglycaemia is a significant complication of fasting during Ramadan. It may be predicted by type of diabetes, and use of insulin. Patients' responses are varied and call for more formal pre-Ramadan education.

Prevalence of Chronic Diabetic Complications in Newly Diagnosed versus Known Type 2 Diabetic Subjects in a Sample of Alexandria Population, Egypt.

BACKGROUND: In Egypt, data on the prevalence of chronic diabetic complications, which are essential for the adjustment of policies and practices related to diabetes care, are scarce. Therefore, the aim of this study was to determine the frequency of chronic complications of diabetes; namely neuropathy, Diabetic Kidney Disease (DKD), retinopathy and Peripheral Arterial Disease (PAD) in newly-diagnosed versus known type 2 diabetic patients. SUBJECTS & METHODS: This is a cross-sectional study that is based on a previous household survey conducted on a representative sample of the population of Alexandria, Egypt. This study included 506 consecutive subjects with type 2 diabetes; 323 patients with previously known T2DM and 183 patients with newly diagnosed T2DM (discovered during the survey). For each participant, a focused history was taken. Comprehensive clinical examination was done including fundus examination, foot examination and assessment of ankle brachial index. Laboratory tests included HbAlc, lipids profile, serum creatinine and Urinary Albumin Creatinine Ratio (UACR). RESULTS: Peripheral neuropathy was detected in 20% of the studied patients; 29.4% of known patients and 3.3% of newly diagnosed patients (p<0.001). Diabetic kidney disease was detected in 33.2% of the studied patients; 46.1% of known patients and 10.4% of newly diagnosed patients (p<0.001). Diabetic retinopathy was detected in 34.6% of the studied patients; 48.3% of known patients and 10.4% of newly diagnosed patients (p<0.001). Peripheral arterial disease was detected in 32.6% of the studied patients; 45.5% of known patients and 9.8% of newly diagnosed patients (p<0.001). In patients with known diabetes, the presence of any of the studied complications (neuropathy, diabetic kidney disease, retinopathy or PAD) was significantly associated with the presence of all other complications (p< 0.001). In patients with newly-diagnosed diabetes, the presence of diabetic kidney disease was significantly associated with the presence of retinopathy (p<0.001), with no significant association with PAD (p=0.357). CONCLUSION: The present study confirms that a considerable proportion of people with T2DM have microvascular complications and/or PAD at the time of, and possibly years before, diagnosis. Having shown that, it is strongly recommended to apply appropriate screening strategies for subjects with diabetes at the time of diagnosis. Finally, these results should be considered as a call for action for the health care planners and providers in our region to plan for early screening for diabetes and its complications to reduce the disease burden in our community.

Prevalence of type 2 diabetes mellitus in a sample of the adult population of Alexandria, Egypt.

AIMS: To determine the prevalence of type 2 diabetes mellitus in a sample of the adult population of Alexandria, Egypt, and to delineate the epidemiologic profile of the disease in this community. METHODS: This cross-sectional study was conducted on a representative sample of the population. Participants provided demographic data, their medical history, and blood samples for measurement of plasma glucose (fasting and after oral glucose load) and underwent a detailed physical examination. RESULTS: Of 10,640 eligible subjects, 9657 (90.8%) aged 18-90 years agreed to participate (3795 men, 5862 women). We found an age-adjusted prevalence of diabetes of 16.8% (men, 12.7%; women 19.1%); of prediabetes, 14.6% (men, 13.5%; women, 15.2%), and of newly diagnosed diabetes, 5.5% (men, 3.3%; women, 6.6%). Diabetes was most common in people older than 50 years; prediabetes was most common in 30-39-year-old men and in women younger than 20. In logistic regression analysis, factors independently associated with prediabetes were a history of dyslipidaemia, urban residence, and widowhood. Independent associated factors for diabetes were a high waist-to-hip ratio, family history of diabetes, being divorced, history of dyslipidaemia, peripheral arterial disease or hypertension, low education level, and being not working. CONCLUSIONS: We found a high prevalence of diabetes and prediabetes in Alexandria, particularly in the middle-aged population. Given globally increasing life expectancies, the number of individuals with diabetes could become particularly challenging to the Egyptian healthcare system. Comprehensive national preventive measures are urgently needed.

Expert Opinion: Patient Selection for Premixed Insulin Formulations in Diabetes Care.

Premixed insulins are an important tool for glycemic control in persons with diabetes. Equally important in diabetes care is the selection of the most appropriate insulin regimen for a particular individual at a specific time. Currently, the choice of insulin regimens for initiation or intensification of therapy is a subjective decision. In this article, we share insights, which will help in rational and objective selection of premixed formulations for initiation and intensification of insulin therapy. The glycemic status and its variations in a person help to identify the most appropriate insulin regimen and formulation for him or her. The evolution of objective glucometric indices has enabled better glycemic monitoring of individuals with diabetes. Management of diabetes has evolved from a 'glucocentric' approach to a 'patient-centered' approach; patient characteristics, needs, and preferences should be evaluated when considering premixed insulin for treatment of diabetes.Funding: Novo Nordisk, India.

Serum chemerin and high-sensitivity C reactive protein as markers of subclinical atherosclerosis in Egyptian patients with type 2 diabetes.

CONTEXT: Chemerin is one of the adipokines that regulate fat metabolism. High-sensitivity C-reactive protein (hs-CRP) may be considered as a cardiovascular risk predictor. Measuring intima-media thickness of the CCA (C-IMT) is a well-evidenced tool for the detection of early stages of atherosclerosis. We aimed here to study both serum chemerin and hs-CRP as markers of subclinical atherosclerosis in Egyptian patients with type 2 diabetes, who are angiographically free of coronary artery disease (CAD). SUBJECTS AND METHODS: This cross-sectional study was conducted on 180 subjects divided into two groups: Group A included 90 type 2 diabetic patients without CAD and group B including 90 nondiabetic control subjects. All study subjects were having normal coronary angiography. Serum chemerin, homeostasis model assessment for insulin resistance (HOMA-IR), glycated haemoglobin (HbA1c), lipid profile, hs-CRP as well as C-IMT were assessed in all study subjects. RESULTS: There was a statistically significant difference between the 2 groups regarding serum chemerin level, HOMA-IR, hs-CRP and C-IMT; being higher in the diabetic patients than in the control group (p = 0.006, 0.024, 0.040 and <0.001, respectively). There was positive correlation between serum chemerin level and waist-to-hip ratio (WHR), HOMA-IR, hs-CRP and C-IMT. Carotid intima-media thickness was positively correlated with patients' WHR, blood pressure, HbA1c, diabetes duration as well as hs-CRP, and negatively correlated with ankle-brachial index (ABI). Linear regression analysis showed that HbA1c, serum chemerin and hs-CRP were independently affecting C-IMT. Serum hs-CRP was positively correlated with HbA1c and HOMA-IR (p = 0.006 and 0.032, respectively), and negatively correlated with HDL-cholesterol level (p = 0.018). CONCLUSION: Both serum chemerin and hs-CRP could be considered as markers of subclinical atherosclerosis, and hence, may be utilized for the early detection of macrovascular disease, in Egyptian patients with type 2 diabetes.

Optimal waist circumference cutoff points for the determination of abdominal obesity and detection of cardiovascular risk factors among adult Egyptian population.

OBJECTIVE: To determine the best anthropometric measurement of obesity, and its optimal cutoff, that best predicts the presence of cardiovascular risk factors among adult Egyptian population. METHODS: This is a cross-sectional study including a representative randomly chosen sample of the adult Egyptian population from all Alexandria Districts (the second largest governorate in Egypt) based on the multistage random technique. It included 3209 subjects (1567 men, 1642 women) aged 18-80 years from urban and rural areas. The response rate was 80.2%. History, blood pressure, and anthropometric measurements were taken. Laboratory investigations included fasting lipid profile, fasting plasma glucose, and serum uric acid. Different criteria of metabolic syndrome were used and compared. Receiver operator characteristic curve and Youden index were used to determine predictability and cutoffs. RESULTS: Waist circumference (WC) is the best to predict at least two other components of the metabolic syndrome as defined by the International Diabetes Federation (IDF). The optimal WC cutoffs were 100.5 and 96.25 cm for Egyptian men and women, respectively. The Joint Interim Statement definition (JIS) of metabolic syndrome was the best to predict cardiovascular disease in both genders and diabetes mellitus in women. The prevalence of metabolic syndrome and abdominal obesity was 42.5%, 61%, respectively (ATPIII definition); 43.8%, 61% (American Heart Association definition); 44.3%, 76.4% (IDF definition); 33.8%, 51.7% (IDF definition with Egyptian cutoffs); and 41.5%, 51.7% (JIS with Egyptian cutoffs). CONCLUSION: WC cutoffs in Egyptians differ from those currently recommended. Prevalence of metabolic syndrome and abdominal obesity is high in Egypt, despite being lower on using the Egyptian cutoffs.

Resveratrol promotes foot ulcer size reduction in type 2 diabetes patients.

Objective. The effect of a proprietary formulation of trans-resveratrol (t-RSV) on manifestations of diabetic foot syndrome (DFS) was studied in type 2 diabetic patients with newly diagnosed diabetic foot ulcers. Method. Placebo-controlled, examiner-blinded, parallel-group randomized controlled pilot clinical trial (ACTRN Clinical Trial Registry number 12610000629033) involving 24 patients with DFS (15 males and 9 females, average age of 56.4 ± 9.1 years) divided into the placebo and RSV-treatment groups was performed. 50 mg of t-RSV or placebo capsules was given to each patient twice a day over a 60-day time period. Results. Reduction in the parameters reflecting diabetic ulcer size was more profound in the RSV group as compared to placebo. RSV-treated patients also had a marginally improved performance in the foot pressure test. A statistically significant decline in the plasma fibrinogen level, but not CRP, was also found in the RSV-treated patients. Some improvement in the plasma lipid profile and fasting glucose levels were not related to RSV-treatment, since they have been seen on both the RSV and placebo groups, revealing the effectiveness of medical supervision and education in the newly diagnosed patients with DFS. Conclusion. t-RSV supplementation promotes reduction of the foot ulcer size and reduces plasma fibrinogen level in type 2 diabetic patients.

Perspectives on patient-centered care in diabetology.

Much has been written about patient-centered care (PCC) in medical literature. PCC has been praised as the ultimate objective of medicine by some. However, critics have pointed out the obvious: The antonym of PCC is doctor-centered medical care. Is doctor-centered care wrong? And what do we practice if we do not follow PCC? Can physicians transfer all responsibility for decision making to patients, in the name of PCC? Do patients have a right to choose outcomes, and make clinical decisions to achieve those outcomes? Most of the work on PCC has been done in the fields of family medicine and primary care. Minimal publications are available to highlight the role of PCC in endocrinology and diabetology. This brief communication discusses some concepts of PCC, and expands upon this term, to assess its relevance to diabetology.