Real-World Study on Effectiveness of Insulin Glargine U300 After Oral Antidiabetic Drug Failure in Patients with Type 2 Diabetes in the Gulf Region.

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.

Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Who Fast During Ramadan in The Gulf Region: A Subgroup Analysis of the Real-World ORION Study.

INTRODUCTION: To evaluate the safety and effectiveness of insulin glargine 300 U/mL (Gla-300) in people with type 2 diabetes mellitus (T2DM) in the Gulf region who fast during Ramadan. METHODS: ORION was a real-world, prospective, observational study in people with T2DM treated with Gla-300 during pre-Ramadan, Ramadan, and post-Ramadan periods. This subgroup analysis included 222 participants from the Gulf region (Kuwait, Saudi Arabia, United Arab Emirates, and Qatar). The primary endpoint was the percentage of participants experiencing severe and/or symptomatic documented hypoglycemia (self-monitored plasma glucose [SMPG] ≤ 70 mg/dL) during Ramadan. Changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), SMPG, body weight, insulin dose, and adverse events (AEs) were also evaluated. RESULTS: The primary endpoint was reported in one (0.5%) participant during Ramadan. The incidence rate of symptomatic documented hypoglycemia (SMPG ≤ 70 mg/dL) decreased from the pre-Ramadan (3.2%) to Ramadan period (0.5%), and no severe hypoglycemia events were reported during the study. Reductions were observed in HbA1c (mean ± standard deviation: - 0.51 ± 0.95% [- 5.5 ± 10.4 mmol/mol]), FPG (- 13.9 ± 47.5 mg/dL), and SMPG (- 6.1 ± 27.1 mg/dL). No significant changes were observed in body weight or Gla-300 dose. AEs were reported in 11 (5.0%) participants. CONCLUSION: In a real-world setting in the Gulf region, Gla-300 treatment in people with T2DM during Ramadan was associated with a low incidence of hypoglycemia and improved glycemic control. TRIAL REGISTRATION: CTRI/2019/02/017636.

Treatment Patterns, Effectiveness, and Satisfaction Among Patients with Type 2 Diabetes Treated with Insulin in Saudi Arabia: Results of the RIMODIS Study.

INTRODUCTION: The alarming increase in type 2 diabetes mellitus (T2DM) in Saudi Arabia is aggravated by increasing obesity, sedentary lifestyle, and population aging. The RIMODIS study aimed at describing the practices in the therapeutic management of patients with T2DM treated with different insulin regimens. METHODS: This national, multicenter, non-interventional, cross-sectional disease registry on the real-life therapeutic management of insulin-treated patients with T2DM in Saudi Arabia enrolled 3010 patients. It primarily aimed at describing treatment patterns, complications, and glycemia levels. Patients completed the diabetes treatment satisfaction questionnaire (DTSQ). Data on different treatment patterns were analyzed using chi-square or Fisher's exact test. Outcomes were analyzed according to the different insulin regimen subgroups (basal versus premixed). RESULTS: Over 60% of patients were treated with premixed insulin and most patients were also prescribed oral antidiabetics (OADs). Patients on insulin alone seemed to achieve better glycated hemoglobin (HbA1c) control. Adding OADs to insulin slightly increased treatment satisfaction scores, with scores higher in patients on basal insulin compared to premixed insulin. Hypoglycemia was lower when adding OADs to insulin. Most patients showed high treatment adherence; however, two-thirds of study patients failed to achieve glycemic target levels. CONCLUSION: Most patients are treated with a combination of insulin and OADs, associated with glycemic control and low incidence of hypoglycemia. However, we highlight suboptimal glycemic target achievement, underscoring the need to improve T2DM clinical management and promote healthier lifestyle among patients in Saudi Arabia.