Effectiveness and safety of insulin glargine plus glimepiride after 6 months of treatment among patients with type 2 diabetes mellitus who failed premixed insulin: An observational study conducted in Egypt

Objective This study aimed to evaluate the effectiveness and safety of insulin glargine in combination with glimepiride treatment in daily practice in patients who failed premixed insulin with or without oral antidiabetic (OAD) regimen. Patients and methods This 6-month, prospective, multicenter, observational study conducted in Egypt included adult patients with type 2 diabetes mellitus on premix with or without OAD (glimepiride plus metformin), with glycated hemoglobin (HbA1c) greater than 8.5% and for whom the investigator decided to switch to insulin glargine in addition to glimepiride. Overall, three mandatory visits (baseline, 3 months, and 6 months) and seven phone calls were performed by the investigator for each eligible patient. Patients were assessed according to the value of HbA1c and fasting blood glucose (FBG). Results At the end of this study, the results showed effectiveness of combining insulin glargine plus glimepiride in reducing the mean baseline level of HbA1c% by 1.79 and 2.5% at visit 2 (week 12) and visit 3 (week 24), respectively (P<0.001). The percentage of patients reaching target HbA1c less than 7% in visit 2 (week 12) and visit 3 (week 24) was 5 and 24.3%, respectively. They also showed a significant reduction (P<0.001) in the mean FBG at visit 2 (week 12) and visit 3 (week 24) of 97.44 and 104.4 mg/dl, respectively, whereas the mean percent reductions were 44.37 and 47.54%, respectively. The percentage of patients who reaching FBG less than or equal to 100 mg/dl was 26.7 and 32.2%, in visit 2 (week 12) and visit 3 (week 24), respectively. There was no significant change in mean body weight between baseline and visit 3 (P>0.05). The mean 2-h postprandial blood glucose level was decreased significantly (P<0.001) at visit 2 to 171.93±68.2 mg/dl and at visit 3 to 155.88±56.61 mg/dl. The mean reductions of 2-h postprandial blood glucose at weeks 12 and 24 were 140.8 and 156.8 mg/dl, respectively, and the mean percentage reductions were 45 and 50.1%, respectively. A total of 50 adverse events were reported by 41 patients during the study. The most frequently reported adverse event was hypoglycemia, which included 37 episodes reported by 31 patients, where nocturnal hypoglycemia was represented in 12 episodes, with percentage of 32.4%. Conclusion The results showed that a combination therapy of insulin glargine and glimepiride improved glycemic control in patients with type 2 diabetes mellitus, who failed premixed with or without OAD (glimepiride plus metformin). In addition, safety analysis showed high patient tolerability to glargine and glimepiride regimen.