Table 1—

Demographic and baseline characteristics and week 24 outcome data for patients with type 2 diabetes poorly controlled on metformin monotherapy randomized to adjunctive INH versus adjunctive glibenclamide

ParameterINH + metformin
Glibenclamide + metformin
CombinedA1C >9.5%A1C ≤9.5%CombinedA1C >9.5%A1C ≤9.5%
n (male/female)239 (136/103)109 (62/47)130 (74/56)231 (132/99)105 (53/52)126 (79/47)
n (completing 24 weeks)2139611720195106
Age (years)55.5 (35–77)54.6 (35–74)56.2 (35–77)55.5 (36–77)54.4 (36–77)56.3 (37–74)
Weight (kg)90.5 (55–168)89.6 (60–162)91.2 (55–168)88.2 (47–131)87.8 (50–125)88.6 (47–131)
BMI (kg/m2)31.8 (19–51)31.7 (22–47)31.8 (19–51)31.1 (22–47)31.1 (22–47)31.2 (22–45)
Diabetes duration (years)8.4 (0.6–35.6)9.2 (0.6–35.6)7.7 (0.6–30.3)7.8 (0.3–29.5)8.4 (0.5–29.5)7.4 (0.3–27.5)
Fasting C-peptide (pmol/ml)1.20 (0.30–4.60)1.30 (0.36–4.60)1.12 (0.36–4.20)1.29 (0.26–6.50)1.41 (0.30–6.50)1.19 (0.26–4.40)
INH + metformin
Glibenclamide + metformin
Difference between adjusted mean change (95% CI)*
BaselineWeek 24 (LOCF)BaselineWeek 24 (LOCF)
Average total daily dose of study drug (mg)
    Combined10.1 ± 5.013.2 ± 7.34.5 ± 1.57.6 ± 3.0
    A1C >9.5%11.4 ± 5.114.9 ± 7.74.8 ± 1.38.5 ± 2.4
    A1C ≤9.5%9.0 ± 4.711.8 ± 6.74.3 ± 1.76.8 ± 3.3
A1C (%)
    Combined9.46 ± 1.057.34 ± 0.989.57 ± 1.117.52 ± 1.13−0.17 (−0.34 to 0.01); P = 0.058
    A1C >9.5%10.40 ± 0.707.50 ± 1.1310.56 ± 0.737.97 ± 1.22−0.37 (−0.62 to −0.12); P = 0.004
    A1C ≤ 9.5%8.64 ± 0.457.20 ± 0.818.71 ± 0.507.13 ± 0.880.04 (−0.19 to 0.27); P = 0.733
Patients achieving A1C <8%, n (%)Odds ratio (95% CI)
    Combined180 (76.9)161 (72.5)1.12 (0.70–1.80)
    A1C >9.5%79 (72.5)58 (56.3)1.91 (1.02–3.55)
    A1C ≤ 9.5%101 (80.8)103 (86.6)0.49 (0.23–1.06)
Patients achieving A1C <7%Odds ratio (95% CI)
    Combined87 (37.2)69 (31.1)1.32 (0.87–2.00)
    A1C >9.5%37 (33.9)18 (17.5)2.54 (1.27–5.08)
    A1C ≤9.5%50 (40.0)51 (42.9)0.85 (0.49–1.46)
Mean insulin antibodies (μU/ml)1.25 ± 3.2611.65 ± 28.741.03 ± 0.301.01 ± 0.15
Median percentage binding1.004.301.001.00
FPG (mmol/l)203.0 ± 56.0161.0 ± 43.0216 ± 54.0164 ± 48.00.98 (−7.13 to 9.10)
2-h PPG (mmol/l)§216.3 ± 49.6155.7 ± 32.6227.8 ± 48.1169.2 ± 42.8−11.08 (−18.37 to −3.78)
Total cholesterol (mmol/l)5.09 ± 1.085.13 ± 0.925.26 ± 1.025.23 ± 1.020.02 (−0.11 to 0.14)
LDL cholesterol (mmol/l)2.97 ± 0.913.07 ± 0.833.07 ± 0.843.10 ± 0.820.04 (−0.07 to 0.14)
Triglycerides (mmol/l)2.20 ± 1.521.87 ± 1.072.54 ± 2.012.27 ± 1.89−0.16 (−0.34 to 0.01)
HDL cholesterol (mmol/l)1.18 ± 0.311.25 ± 0.361.14 ± 0.311.18 ± 0.350.05 (−0.001 to 0.10)
FEV1 (l)2.99 ± 0.722.90 ± 0.742.93 ± 0.722.89 ± 0.72−0.04 (−0.084 to 0.004)
DLCO (ml · min−1 · mmHg−1)26.75 ± 6.7526.32 ± 6.6726.41 ± 6.3125.63 ± 6.270.23 (−0.45 to 0.90)
FVC (l)3.64 ± 0.873.58 ± 0.883.60 ± 0.903.55 ± 0.91−0.008 (−0.061 to 0.045)
TLC (l)5.73 ± 1.195.78 ± 1.295.74 ± 1.225.66 ± 1.240.116 (0.002–0.231)
  • Data are n (%), means ± SD, or means (range).

  • *

    * Values are difference between adjusted mean change unless specified otherwise.

  • Average total daily INH and glibenclamide dose at week 4.

  • Fasting plasma glucose (FPG), after at least an 8-h fast, was measured at weeks 0, 6, 18, and 24. The change from baseline in FPG was calculated from the average of all available week 0 and 24 values.

  • §

    § 2-h postprandial plasma glucose (PPG) was calculated from home glucose measurements; a 24-h home glucose profile (seven samples per day, taken before and 2 h after each meal and at bedtime) was obtained 6, 4, and 2 days prior to the week 0 and 24 clinic visits. The change from baseline in 2-h PPG was calculated as the average of all available postprandial data across all meals. FVC, forced vital capacity; LOCF, last observation carried forward; TLC, total lung capacity.