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

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

Research output: Contribution to journalArticle

8 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)731-739
Number of pages9
JournalPostgraduate medicine
Volume128
Issue number8
DOIs
StatePublished - Nov 16 2016

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

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    Oster, G., Sullivan, S. D., Dalal, M. R., Kazemi, M. R., Rojeski, M., Wysham, C. H., Sung, J., Johnstone, B., Cali, A. M. G., Wei, L. J., Traylor, L., Anhalt, H., Hull, M., Van Vleet, J., & Meneghini, L. F. (2016). Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes. Postgraduate medicine, 128(8), 731-739. https://doi.org/10.1080/00325481.2016.1241663