A Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide Modified Release during Fasting in Gulf Cooperation Council Countries: An Analysis from the International DIA-RAMADAN Study

Introduction: The safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) who fasted during Ramadan were previously published. Here, we carried out a regional analysis among patients living in Gulf Cooperation Council (GCC) countries. Patients and Methods: DIA-RAMADAN was a real-world, observational, international, noncomparative study conducted in nine countries that included >1200 T2DM adults receiving gliclazide MR for at least 90 days before inclusion. The study comprised 2 visits: at inclusion, 6–8 weeks before the start of Ramadan (V0) and 4–6 weeks after the end of Ramadan (V1). The primary endpoint was the proportion of patients reporting ≥1 symptomatic hypoglycemic event as collected using a patient diary. Changes in HbA1c, fasting plasma glucose (FPG), and weight were also analyzed. This manuscript represents data collected in GCC countries (Kuwait, Saudi Arabia, and United Arab Emirates). Results: Data from 161 patients were analyzed: mean (SD) age 56.8 (10.6) years, 30.4% women, body mass index 29.1 (3.7) kg/m2, T2DM disease duration 6.7 (3.3) years, baseline HbA1c 7.9% (0.8). The proportions of patients reporting ≥1 symptomatic hypoglycemic event or confirmed hypoglycemia during Ramadan were 4.3% and 0.6%, respectively. No cases of severe hypoglycemia were reported. Significant reductions in main variables were observed before the start of Ramadan (V0) and 4–6 weeks after the end of Ramadan (V1): HbA1c (from 7.9 [0.8] to 7.6 [0.7]%; p value <0.001), FPG (from 143.5 [24.3] to 137.9 [25.2] mg/dL; p value = 0.031), and weight (from 79.0 [73.0–86.0] to 78.0 [72.0–85.0] kg; p value = 0.018). Conclusions: These real-world data indicate that patients with T2DM treated with gliclazide MR during Ramadan in the selected GCC countries have a low risk of hypoglycemia and maintain glycemic control and weight while fasting

Advancing therapy in suboptimally controlled basal insulin-treated type 2 diabetes:Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial

OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin–treated type 2 diabetes (HbA(1c) ≥7.5% and ≤10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA(1c) reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. RESULTS: Both primary efficacy end points were met: after 26 weeks, baseline HbA(1c) (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference −0.2% [97.5% CI −0.4, −0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference −1.9 kg [95% CI −2.3, −1.4]) and percentage of participants achieving HbA(1c) <7% without weight gain and HbA(1c) <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA(1c) reduction (P < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30. CONCLUSIONS: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy. VIDEO 1: [Figure: see text] [Figure: see text

Filling the Knowledge Gap in Diabetes Management During Ramadan: the Evolving Role of Trial Evidence

<p><strong>Article full text</strong></p> <p><br> The full text of this article can be found <a href="https://link.springer.com/article/10.1007/s13300-016-0168-9"><b>here</b>.</a><br> <br> <strong>Provide enhanced digital features for this article</strong><br> If you are an author of this publication and would like to provide additional enhanced digital features for your article then please contact <u>[email protected]</u>.<br> <br> The journal offers a range of additional features designed to increase visibility and readership. All features will be thoroughly peer reviewed to ensure the content is of the highest scientific standard and all features are marked as ‘peer reviewed’ to ensure readers are aware that the content has been reviewed to the same level as the articles they are being presented alongside. Moreover, all sponsorship and disclosure information is included to provide complete transparency and adherence to good publication practices. This ensures that however the content is reached the reader has a full understanding of its origin. No fees are charged for hosting additional open access content.<br> <br> Other enhanced features include, but are not limited to:<br> • Slide decks<br> • Videos and animations<br> • Audio abstracts<br> • Audio slides<u></u></p> <p> </p> <p> </p> <p> </p

Prevalence of lipid abnormalities and cholesterol target value attainment in patients with coronary heart disease in Saudi Arabia

Introduction: Hyperlipidemia is highly prevalent among patients surviving an acute coronary syndrome (ACS) and those with stable coronary heart disease (CHD). Evidence-based guidelines advocate specific target LDL-C levels depending on patient risk; however, it is unclear to what extent these targets have been met in ACS and CHD patients in Saudi Arabia. Methodology: A multicenter observational study, data were collected from treated patients with stable CHD or those presenting with an ACS at any of the four participating sites in Saudi Arabia. Patients were enrolled from December 2013 to October 2014. Individuals were included if they were over 18 years of age and had a full lipid profile available, recorded either prior to the baseline physician visit (stable CHD patients) or within 24 h of admission to hospital (ACS patients). Results: A total of 737 patients were included in the study, 597 with stable CHD and 140 with ACS. Approximately 78% of the patients were male, and comorbidities and cardiovascular risk factors were highly prevalent. Few patients in either group had an LDL-C level of <70 mg/dl, which is advocated for very high-risk patients (24.3% and 11.4%, respectively). The median distances to this value were 19.0 mg/dl and 25.0 mg/dl for the CHD and ACS patients, respectively. Only low doses of statins were being utilized for both groups. For the ACS patients, LLT was intensified after hospital admission; however, the mean statin dosage remained low 4 months after the ACS event. Conclusion: Achievement of recommended LDL-C levels was poor for both patients with stable CHD and those admitted to hospital as a result of an ACS. Statin intensity was low, indicating huge scope for improving the treatment of these very high risk patients

Incidence of hypoglycemia in patients with type 2 diabetes treated with gliclazide versus DPP-4 inhibitors during Ramadan: A meta-analytical approach

Aim: Hypoglycemia can be a concern for patients with type 2 diabetes when fasting during Ramadan. In this analysis, we assessed the incidence of symptomatic hypoglycemic events in fasting patients treated with gliclazide or dipeptidyl peptidase-4 (DPP-4) inhibitors

Prevalence of lipid abnormalities and cholesterol target value attainment in patients with stable coronary heart disease or an acute coronary syndrome in Saudi Arabia

Objectives: To provide an overview of the extent of hyperlipidemia in very high-risk patients, and how lipid-lowering therapy (LLT) is used in a real-world setting. Methods: In this multicenter observational study, data were collected from LLT-treated patients with stable CHD or an ACS in Saudi Arabia between 2013 and 2014. Individuals were included if they were greater than 18 years and had a full lipid profile available, recorded either prior to the baseline physician visit (CHD patients) or within 24-hours of admission to hospital (ACS patients). Results: A total of 737 patients were included in the study, 597 with stable CHD and 140 with ACS. Few patients in either group had an LDL-C level of greater than 70 mg/dl, which is advocated for very high-risk patients (24.3% and 11.4%, respectively). The median distances to this value were 19.0 mg/dl (CHD) and 25.0 mg/dl (ACS). Low doses of statins were being utilized (31 and 24 mg/day for CHD and ACS, respectively), with only minimal intensification for the ACS patients after hospital admission (41 mg/day at follow-up). Conclusions: Achievement of recommended LDL-C levels was poor for patients with stable CHD or an ACS. Statin intensity was low, indicating huge scope for intensifying the treatment of these very high-risk patients

Distribution of single and multiple combined lipid abnormalities.

<div><p>3a. Non-very high risk patients (ESC 2011, SCORE <10%) with at least one lipid abnormality.</p> <p>3B. Very high risk patients (ESC 2011, CVD, diabetes and/or ESC-SCORE ≥10%) with at least one lipid abnormality.</p> <p>3C. Non-very high risk patients (ESC 2011, SCORE <10%).</p> <p>3D. Very high risk patients (ESC 2011, CVD, diabetes and/or ESC-SCORE ≥10%).</p> <p>3E. Patients with at least one lipid abnormality.</p> <p>3F. Patients with total lipid profile.</p></div