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Post Hoc Analysis Evaluating the Impact of Antihyperglycemic Background Therapies on Attainment of A1C Targets Without Hypoglycemia in the ACHIEVE Control Pragmatic, Real-Life Study.
Bailey, Timothy S; Evenou, Pierre; Gill, Jasvinder; Berhanu, Paulos; Raymond, Romain; Strong, Jodi; Wright, Eugene E.
Affiliation
  • Bailey TS; AMCR Institute, Escondido, CA.
  • Evenou P; Sanofi UK, Reading, UK.
  • Gill J; Sanofi US, Inc., Bridgewater, NJ.
  • Berhanu P; Sanofi US, Inc., Bridgewater, NJ.
  • Raymond R; Ividata, Levallois-Perret, France.
  • Strong J; Ascension Health, Stevens Point, WI.
  • Wright EE; Charlotte Area Health Education Center, Charlotte, NC.
Diabetes Spectr ; 34(4): 407-418, 2021 Nov.
Article in En | MEDLINE | ID: mdl-34866875
ABSTRACT

BACKGROUND:

ACHIEVE Control, a prospective, open-label, randomized, pragmatic, real-life study in insulin-naive people with type 2 diabetes (A1C 8.0-11.0%), demonstrated superiority of insulin glargine 300 units/mL (Gla-300) versus first-generation standard-of-care basal insulin (SOC-BI; glargine 100 units/mL or insulin detemir) in achieving individualized A1C targets without documented symptomatic (glucose ≤3.9 mmol/L [≤70 mg/dL] or <3.0 mmol/L [<54 mg/dL]) or severe hypoglycemia (American Diabetes Association level 3) at 6 months. Noninsulin antihyperglycemic background therapies are commonly used; however, sulfonylureas may increase hypoglycemia risk. This post hoc analysis assessed outcomes according to background therapy.

METHODS:

Subgroup analyses were performed per concomitant use/nonuse of sulfonylureas, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase 4 inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors. End points (6 and 12 months) included A1C target attainment without documented symptomatic or severe hypoglycemia, A1C target attainment, and absence of documented symptomatic or severe hypoglycemia.

RESULTS:

Odds ratios (ORs) at 12 months mostly favored Gla-300 versus SOC-BI across subgroups except in analysis of SGLT2 inhibitors, in which ORs were similar. Among sulfonylurea users, ORs at 12 months strongly favored Gla-300 versus SOC-BI for all end points, particularly A1C target achievement without documented symptomatic hypoglycemia (glucose ≤3.9 mmol/L [≤70 mg/dL]; OR 1.25, 95% CI 1.02-1.53) or severe hypoglycemia and achievement of no documented symptomatic hypoglycemia (glucose <3.0 mmol/L [<54 mg/dL]; OR 1.25, 95% CI 1.02-1.52) or severe hypoglycemia.

CONCLUSION:

The results suggest that, in insulin-naive people with type 2 diabetes, Gla-300 is effective with a risk of hypoglycemia that is lower than or similar to that of SOC-BI regardless of background medication. Individuals receiving concomitant sulfonylureas were more likely to remain without symptomatic or severe hypoglycemia with Gla-300.

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials Language: En Journal: Diabetes Spectr Year: 2021 Document type: Article Affiliation country: Canada

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials Language: En Journal: Diabetes Spectr Year: 2021 Document type: Article Affiliation country: Canada
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