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


CONCLUSIONS
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.


BACKGROUND
www.clinicaltrials.gov identifier is NCT02451137.
a Policy Analysis Inc. , Brookline , MA , USA.
Gerry
G
Oster
b University of Washington , Seattle , WA , USA.
Sean D
SD
Sullivan
c Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. , Cambridge , MA , USA.
Mehul R
MR
Dalal
d Abbott Diabetes Care , Alameda , CA , USA.
Mahmood R
MR
Kazemi
e Sanofi US Inc. , Bridgewater , NJ , USA.
Maria
M
Rojeski
f Rockwood Clinic , Spokane , WA , USA.
Carol H
CH
Wysham
e Sanofi US Inc. , Bridgewater , NJ , USA.
Jennifer
J
Sung
e Sanofi US Inc. , Bridgewater , NJ , USA.
Bryan
B
Johnstone
g Sanofi , Paris , France.
Anna M G
AM
Cali
h Harvard T.H. Chan, School of Public Health , Boston , MA , USA.
L J
LJ
Wei
e Sanofi US Inc. , Bridgewater , NJ , USA.
Louise
L
Traylor
i T1D Exchange , Boston , MA , USA.
Henry
H
Anhalt
e Sanofi US Inc. , Bridgewater , NJ , USA.
Michelle
M
Hull
e Sanofi US Inc. , Bridgewater , NJ , USA.
John
J
Van Vleet
j University of Texas Southwestern Medical Center and Parkland Health & Hospital System , Dallas , TX , USA.
Luigi F
LF
Meneghini
D000368:Aged; D001786:Blood Glucose; D001835:Body Weight; D015897:Comorbidity; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D000067757:Glucagon-Like Peptide-1 Receptor / Q000037:antagonists & inhibitors; D006442:Glycated Hemoglobin; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D007003:Hypoglycemia; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000069057:Insulin Detemir / Q000008:administration & dosage / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D000071066:Patient Reported Outcome Measures; D014481:United States
D001786:Blood Glucose; D000067757:Glucagon-Like Peptide-1 Receptor; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D000069036:Insulin Glargine
Comparative effectiveness research; disease management; insulin; methodology; pragmatic clinical trial; real-world setting; type 2 diabetes