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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
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Clinical Diabetes and Endocrinology

ISSN: 2055-8260

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