Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes. Issue 8 (16th November 2016)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Postgraduate medicine. Volume 128:Issue 8(2016)
• Page Start: 731
• Page End: 739
• Publication Date: 2016-11-16
• Subjects: Comparative effectiveness research -- disease management -- insulin -- methodology -- pragmatic clinical trial -- real-world setting -- type 2 diabetes; Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610.5
• DOI: 10.1080/00325481.2016.1241663
• Languages: English
• ISSNs: 0032-5481

Abstract

ABSTRACT: 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-naïve 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 ≥18 years, 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% [64 mmol/mol] in patients with comorbidities or aged ≥65 years; <7.0% [58 mmol/mol] in all other patients) without occurrence of symptomatic hypoglycemia (blood glucose ≤70 mg/dL) from baseline to 6 months. 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.