Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naive patients with type 2 diabetes

作者：Oster Gerry^*; Sullivan Sean D; Dalal Mehul R; Kazemi Mahmood R; Rojeski Maria; Wysham Carol H; Sung Jennifer; Johnstone Bryan; Cali Anna M G; Wei L J; Traylor Louise; Anhalt Henry; Hull Michelle; Van Vleet John; Meneghini Luigi F

来源：Postgraduate Medicine, 2016, 128(8): 731-739.

DOI：10.1080/00325481.2016.1241663

• Comparative effectiveness research
• disease management
• insulin
• methodology
• pragmatic clinical trial
• real-world setting
• type 2 diabetes

Objective: This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia.Methods: Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naive patients with T2D uncontrolled on 2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA). Inclusion criteria include a diagnosis of T2D, age 18years, and glycated hemoglobin (HbA1c) between 8.0% and 11.0%. Patients will be assigned to either the Gla-300 or other basal insulin group. The primary end point is the proportion of patients achieving HEDIS HbA1c targets (<8.0% [64mmol/mol] in patients with comorbidities or aged 65years; <7.0% [58mmol/mol] in all other patients) without occurrence of symptomatic hypoglycemia (blood glucose 70mg/dL) from baseline to 6months. Secondary end points include rates of documented symptomatic nocturnal hypoglycemia and severe hypoglycemia; change from baseline in HbA1c, fasting glucose, and body weight; treatment persistence; patient-reported outcomes; and healthcare resource utilization. Planned enrollment is 3270 patients across approximately 400 clinical sites.Conclusion: Pragmatic clinical trials offer the potential to assess comparative effectiveness in broadly based patient populations receiving care (with or without a corresponding educational support program) in real-world clinical settings. The results of Achieve Control should elucidate the benefits of management of T2D with Gla-300 versus other basal insulins in terms of patient outcomes, experiences, and perceptions, and its impact on healthcare resource utilization and cost.Clinical trial registration: www.clinicaltrials.gov identifier is NCT02451137.

• 出版日期2016