Skip to main content

Table 4 Glycemic response and insulin dose in responders and nonresponders to insulin glargine 100 Units/mL at 24 weeks

From: Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials

  Responders
(HbA1c < 7% or ≥ 1% reduction)
Nonresponders
(HbA1c ≥ 7% and < 1% reduction)
HbA1c (mmol/mol), n 1188 297
 Endpoint 74 (0.44) 89 (0.66)
 CFB − 24 (0.44) − 9 (0.66)
 CFB, LSM Diff (95% CI) − 15 (− 16.40, − 13.88); P < 0.001
HbA1c (%), n 1188 297
 Endpoint 6.76 (0.04) 8.14 (0.06)
 CFB − 2.16 (0.04) − 0.78 (0.06)
 CFB, LSM Diff (95% CI) − 1.38 (− 1.50, − 1.27); P < 0.001
Dose (units/day), n 1187 297
 Endpoint 45.21 (1.36) 42.16 (2.29)
 LSM Diff (95% CI) 3.05 (− 1.24, 7.34); P = 0.164
Dose (units/kg/day), n 1187 297
 Endpoint 0.49 (0.01) 0.47 (0.02)
 LSM Diff (95% CI) 0.02 (− 0.02, 0.07); P = 0.272
Fasting blood glucose, n 692 143
 Endpoint (mmol/L) 6.13 (0.09) 6.83 (0.16)
  CFB − 3.97 (0.09) − 3.26 (0.16)
  CFB, LSM Diff (95% CI) − 0.71 (− 1.00, − 0.41); P < 0.001
 Endpoint (mg/dL) 110.39 (1.63) 123.10 (2.81)
  CFB − 71.48 (1.63) − 58.77 (2.81)
  CFB, LSM Diff (95% CI) −12.71 (− 18.00, − 7.42); P < 0.001
Daily mean SMBG, n 640 128
 Endpoint (mmol/L) 7.30 (0.09) 8.20 (0.16)
  CFB − 3.85 (0.09) − 2.95 (0.16)
  CFB, LSM Diff (95% CI) − 0.90 (− 1.20, − 0.60); P < 0.001
 Endpoint (mg/dL) 131.45 (1.62) 147.70 (2.83)
  CFB − 69.33 (1.62) − 53.08 (2.83)
  CFB, LSM Diff (95% CI) − 16.25 (− 21.60, − 10.89); P < 0.001
Daily mean premeal SMBG, n 678 142
 Endpoint (mmol/L) 6.59 (0.08) 7.51 (0.14)
  CFB − 3.70 (0.08) − 2.78 (0.14)
  CFB, LSM Diff (95% CI) − 0.92 (− 1.19, − 0.65); P < 0.001
 Endpoint (mg/dL) 118.75 (1.52) 135.30 (2.58)
  CFB − 66.64 (1.52) − 50.09 (2.58)
  CFB, LSM Diff (95% CI) − 16.55 (− 21.40, − 11.69); P < 0.001
Daily mean postprandial SMBG, n 677 139
 Endpoint (mmol/L) 8.31 (0.11) 9.32 (0.18)
  CFB − 4.03 (0.11) − 3.02 (0.18)
  CFB, LSM Diff (95% CI) − 1.01 (− 1.36, − 0.66); P < 0.001
 Endpoint (mg/dL) 149.70 (1.93) 167.91 (3.33)
  CFB − 72.70 (1.93) − 54.49 (3.33)
  CFB, LSM Diff (95% CI) − 18.21 (− 24.50, − 11.93); P < 0.001
Intrapatient between-day SMBG variability, n 673 137
 Endpoint (mmol/L) 0.62 (0.03) 0.71 (0.05)
  CFB − 0.27 (0.03) − 0.18 (0.05)
  CFB, LSM Diff (95% CI) − 0.08 (− 0.18, 0.01); P = 0.070
 Endpoint (mg/dL) 11.20 (0.52) 12.74 (0.89)
  CFB − 4.86 (0.52) − 3.33 (0.89)
  CFB, LSM Diff (95% CI) − 1.53 (− 3.19, 0.13); P = 0.070
  1. Endpoints and CFB values are expressed as LSM (SE) unless otherwise stated. Pearson’s Chi-square test was used for categorical variables and ANCOVA model (response = baseline of the response variable + responder + study + study-by-responder interaction + sulphonylurea use [yes/no]) for continuous variables. P values are based on fixed effects meta-regression with a 2-sided α-level of 0.05. Heterogeneity was assessed by study-by-responder interaction. P values for interaction were nonsignificant (≥ 0.05) for outcomes presented with the exception of fasting blood glucose (P = 0.012), indicating results in these trials were relatively homogeneous. All patients had HbA1c values at 24 weeks and received insulin glargine as the only insulin therapy. Abbreviations: CFB change from baseline, CI confidence interval, Diff difference, HbA1c glycated hemoglobin, LSM least squares mean, SE standard error, SMBG self-monitored blood glucose, T2DM type 2 diabetes mellitus