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Effectiveness and safety of basal-bolus therapy (insulin glargine+insulin glulisine) in patients with type 1 diabetes previously uncontrolled on any insulin regimen: multinational phase-IV study

Boudiba A, Al-Arouj M, Robertson LI, Chantelot JM, Al-Rubeaan KA & Charpentier G*

Introduction: Intensive insulin therapy can improve glycemic control and outcomes in patients with Type 1 diabetes as compared to conventional therapy. This study was conducted to evaluate effectiveness and safety of combination of insulin glargine once daily and insulin glulisine thrice daily in patients with type-1-diabetes mellitus previously uncontrolled on other insulin therapies. Methods: This phase-IV, international, open-label, study was conducted in adult type-1-diabetes mellitus patients with glycated hemoglobin between 8%-10%. Study period included a 2-week run-in period and a 24-week treatment period. Change in glycated hemoglobin, fasting blood glucose, 7-point blood glucose mean profile and insulin dose from baseline to week 12 and 24 were evaluated. Safety was assessed by occurrence of adverse events primarily hypoglycemia. Descriptive statistics were used for analysis. Results: From November 2012 to January 2013, 295 patients screened out of which 206 patients were treated. The mean (SE) reduction in glycated hemoglobin and fasting blood glucose from baseline to week 24 was -0.5 ± 0.1% (p<0.001) and -2.0 ± 0.4 mmol/L (p<0.001), respectively. Overall, 12% and 10% of patients achieved glycated hemoglobin <7% after 12-weeks and 24-weeks of treatment, respectively. The mean change in blood glucose level from baseline to week 12 and week 24 was significant (p<0.001) at all time-points, except before lunch and at bedtime. Serious adverse events were reported for 13 (6%) patients; most of them were severe in intensity. Serious adverse events related to insulin glargine and/or insulin glulisine were hypoglycemic seizures (three patients), hypoglycemic unconsciousness (three patients) and hypoglycemia (two patients). Conclusion: Treatment with insulin glargine and insulin glulisine improved glycemic control in patients with type-1-diabetes mellitus. The combination was well tolerated with no new safety concerns.