Gerry Oster1, Sean D Sullivan2, Mehul R Dalal3, Mahmood R Kazemi4, Maria Rojeski5, Carol H Wysham6, Jennifer Sung5, Bryan Johnstone5, Anna M G Cali7, L J Wei8, Louise Traylor5, Henry Anhalt9, Michelle Hull5, John Van Vleet5, Luigi F Meneghini10. 1. a Policy Analysis Inc. , Brookline , MA , USA. 2. b University of Washington , Seattle , WA , USA. 3. c Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. , Cambridge , MA , USA. 4. d Abbott Diabetes Care , Alameda , CA , USA. 5. e Sanofi US Inc. , Bridgewater , NJ , USA. 6. f Rockwood Clinic , Spokane , WA , USA. 7. g Sanofi , Paris , France. 8. h Harvard T.H. Chan, School of Public Health , Boston , MA , USA. 9. i T1D Exchange , Boston , MA , USA. 10. j University of Texas Southwestern Medical Center and Parkland Health & Hospital System , Dallas , TX , USA.
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 ≥2oral 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.
RCT Entities:
OBJECTIVE: This study aims to compare the effectiveness of insulinglargine 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.
Authors: Thomas Semlitsch; Jennifer Engler; Andrea Siebenhofer; Klaus Jeitler; Andrea Berghold; Karl Horvath Journal: Cochrane Database Syst Rev Date: 2020-11-09
Authors: Timothy S Bailey; Fang L Zhou; Rishab A Gupta; Ronald Preblick; Vineet E Gupta; Paulos Berhanu; Lawrence Blonde Journal: Diabetes Obes Metab Date: 2019-04-05 Impact factor: 6.577
Authors: Lawrence Blonde; Stephen A Brunton; Pavan Chava; Rong Zhou; Juliana Meyers; Keith L Davis; Mehul R Dalal; Andres DiGenio Journal: Diabetes Spectr Date: 2019-05
Authors: Luigi F Meneghini; Sean D Sullivan; Gerry Oster; Robert Busch; Anna M G Cali; Arnaud Dauchy; Jasvinder Gill; Timothy S Bailey Journal: Diabetes Obes Metab Date: 2020-09-03 Impact factor: 6.577