ABSTRACT
INTRODUCTION: The effectiveness and safety of long-acting insulin glargine U300 (Gla-300), in patients with type 2 diabetes mellitus (T2DM) requiring insulin, has not been reported in the Gulf region. METHODS: Insulin-naïve patients with T2DM, uncontrolled on OADs, and prescribed Gla-300 were followed up in a 12-month prospective observational study. Gla-300 was titrated to glycemic targets. The primary endpoint (achieving glycemic targets) was evaluated at month 6 of treatment. The need for treatment intensification, safety, and patient-reported outcomes (PRO) were also reported. RESULTS: The study included 412 patients (61.7% men; age 52.2 ± 11.1 years and T2DM duration 10.7 ± 6.8 years). Almost 50% were on more than 3 OADs, mostly biguanides, sulfonylureas, and dipeptidyl-peptidase-4 inhibitors. Baseline HbA1c level was 9.2% ± 1.1% and targets were set at 6.9% ± 0.4%. Baseline fasting plasma glucose was 11.5 ± 3.8 mmol/l. Fifty-seven patients (13.8%) achieved glycemic targets at month 6, hindered by baseline HbA1c ≥ 10%, frequent co-morbidities, older age, suburban/rural residence, and full-time employment. Levels of HbA1c dropped progressively by 0.96% ± 0.07% (month 3), 1.29% ± 0.08% (month 6), and 1.76% ± 0.06% (month 12). Gla-300 dose was 17.0 ± 9.0 IU/day at baseline, 24.6 ± 9.6 IU/day at month 3, 28.5 ± 9.9 IU/day at month 6, and 30.7 ± 10.7 IU/day at month 12. Three patients experienced non-severe hypoglycemia and a slight decrease in body weight and PROs improved. CONCLUSIONS: In the Gulf, Gla-300 in patients with T2DM uncontrolled on OADs improved glycemic control, with low rates of hypoglycemia and improved PROs. Gla-300 dose up-titration from baseline to month 6 did not, however, result in a vast proportion of patients achieving their pre-determined HbA1c targets. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03703869.
ABSTRACT
Type 2 diabetes mellitus (T2DM) and hypertension are leading risk factors for death and disability in the Middle East. Both conditions are highly prevalent, underdiagnosed and poorly controlled, highlighting an urgent need for a roadmap to overcome the barriers to optimal glycaemic and blood pressure management in this region. This review provides a summary of the Evidence in Diabetes and Hypertension Summit (EVIDENT) held in September 2022, which discussed current treatment guidelines, unmet clinical needs and strategies to improve treatment outcomes for patients with T2DM and hypertension in the Middle East. Current clinical guidelines recommend strict glycaemic and blood pressure targets, presenting several treatment options to achieve and maintain these targets and prevent complications. However, treatment targets are infrequently met in the Middle East, largely due to high clinical inertia among physicians and low medication adherence among patients. To address these challenges, clinical guidelines now provide individualised therapy recommendations based on drug profiles, patient preferences and management priorities. Efforts to improve the early detection of prediabetes, T2DM screening and intensive, early glucose control will minimise long-term complications. Physicians can use the T2DM Oral Agents Fact Checking programme to help navigate the wide range of treatment options and guide clinical decision-making. Sulfonylurea agents have been used successfully to manage T2DM; a newer agent, gliclazide MR (modified release formulation), has the advantages of a lower incidence of hypoglycaemia with no risk of cardiovascular events, weight neutrality and proven renal benefits. For patients with hypertension, single-pill combinations have been developed to improve efficacy and reduce treatment burden. In conjunction with pragmatic treatment algorithms and personalised therapies, greater investments in disease prevention, public awareness, training of healthcare providers, patient education, government policies and research are needed to improve the quality of care of patients with T2DM and/or hypertension in the Middle East.
