High Levels of Baseline HbA1c, FPG, and 2-Hour Postprandial Glucose Are Key Predictors for Not Achieving HbA1c < 7.0% at Six Months in People with T2DM Starting Insulin Glargine 100 U/mL

Abstract

Pooled participant-level data from 16 RCTs (≥ 24 weeks) were used to explore the association of demographic and clinical markers with different levels of HbA1c achieved at Week 24 in insulin-naive people with T2DM on oral agents after starting insulin glargine 100 U/mL (Gla-100). A stepwise logistic regression analysis was performed to identify potential predictive and exploratory factors for attaining an HbA1c < 7.0%. In total, 46%, 37%, and 17% of 3,415 participants (53% male) included in the analysis achieved Week 24 HbA1c < 7.0%, 7.0-8.0%, and > 8.0%, respectively. Key clinical findings and multivariate analysis results are shown in the Table. Sex, diabetes duration, baseline BMI, HbA1c, FPG, and overall 2h-PPG were significant predictors of attaining HbA1c < 7.0% at Week 24, whereas change in FPG or 2h-PPG were not. FPG and 2h-PPG levels in the HbA1c > 8.0% group remained highest despite a higher Gla-100 dose (0.52 U/kg) and lower overall hypoglycaemia (PG < 3.9 mmol/L) rate at Week 24. In people with T2DM, high baseline HbA1c, FPG, and PPG levels are important predictors of failure of basal insulin/OAD therapy to achieve desired glycaemic goals. A more active treatment strategy targeting both fasting and postprandial hyperglycaemia appears to be indicated for people with poor glycaemic control after starting basal insulin therapy. Disclosure D.R. Owens: Consultant; Self; Boehringer Ingelheim GmbH, Roche Diagnostics Corporation, Eli Lilly and Company, Sanofi, Takeda Development Centre Europe Ltd.. Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Roche Diagnostics Corporation, Eli Lilly and Company, Sanofi, Takeda Development Centre Europe Ltd. W. Landgraf: Employee; Self; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Self; Sanofi. M. Zhang: Employee; Self; Sanofi US. Stock/Shareholder; Self; Sanofi US. B.M. Frier: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company. Consultant; Self; Locemia Solutions, Zucara Therapeutics. Speaker's Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Roche Pharma, AstraZeneca. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Sanofi US, Novo Nordisk Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; American Diabetes Association. P. Home: Consultant; Self; AstraZeneca. Other Relationship; Self; Biocon, Boehringer Ingelheim GmbH. Research Support; Self; GlaxoSmithKline plc.. Consultant; Self; Hanmi Pharmaceutical. Other Relationship; Self; Janssen Research & Development. Consultant; Self; Janssen Research & Development, Merck & Co., Inc.. Other Relationship; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Other Relationship; Self; Novo Nordisk A/S. Consultant; Self; AntriaBio, Inc., Earlysign, Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Sanofi. Consultant; Self; Sanofi. G.B. Bolli: Speaker's Bureau; Self; Menarini Group, Sanofi. Research Support; Self; Sanofi.