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Table 2 Course of Efficacy Parameters - Absolute Values

From: Double-blind, randomized, multicentre, and active comparator controlled investigation of the effect of Pioglitazone, Metformin, and the combination of both on cardiovascular risk in patients with type 2 diabetes receiving stable basal insulin therapy: the PIOCOMB study

Secondary Efficacy Parameter [Unit] absolute values during the study period: baseline vs. LOCF (full analysis set, n = 113);
displayed as 'arithmetic means ± standard deviation (medians); n patients'
  A: Metformin (n = 39) B: Pioglitazone (n = 37) C: MET + PIO (n = 37)
  Baselinea LOCF Baselinea LOCF Baselinea LOCF
Fasting glucose
[mmol/L] (2)
7.97 ± 1.98 (8.10); 39 7.32 ± 1.90 (6.79); 39 * 8.73 ± 2.58 (8.40); 37 7.34 ± 1.58 (6.99); 37 * 8.21 ± 1.96 (7.81); 37 6.52 ± 1.48 (6.33); 37 *
Fasting insulin
[μIU/mL] (1) (2)
10.44 ± 9.50 (7.20); 39 12.43 ± 10.48 (9.20); 39 * 10.98 ± 7.71 (9.30); 37 7.00 ± 4.41 (5.30); 37 * 8.49 ± 6.94 (5.90); 35 6.10 ± 4.25 (4.60); 35 *
HbA 1C (2) (3)
[%]
7.33 ± 0.53 (7.30); 39 7.23 ± 0.66 (7.10); 39 7.35 ± 0.54 (7.20); 37 7.19 ± 0.73 (7.20); 37 7.34 ± 0.55 (7.30); 37 6.85 ± 0.75 (6.70); 37 *
HOMA-S (1) (2)
[mmol*mU/L 2 ]
3.87 ± 3.89 (2.38); 39 4.14 ± 3.84 (2.64); 39 4.60 ± 3.93 (2.93); 37 2.39 ± 1.79 (1.85); 37 * 3.40 ± 3.73 (1.97); 35 1.80 ± 1.30 (1.22); 35 *
MMP-9
[ng/mL]
601.7 ± 317.0 (544.8); 39 651.3 ± 365.3 (543.3); 39 535.0 ± 214.9 (533.7); 37 480.9 ± 232.4 (443.2); 37 581.8 ± 260.7 (504.5); 37 514.0 ± 219.5 (474.3); 37
MMP-9 - Ln
[ng/mL] (1) (2)
6.3 ± 0.6
(6.3); 39
6.4 ± 0.5
(6.3); 39
6.2 ± 0.4
(6.3); 37
6.1 ± 0.5
(6.1); 37 *
6.3 ± 0.4
(6.2); 37
6.2 ± 0.4
6.2); 37
hs-CRP ≤ 10 (2)
[mg/L]
3.22 ± 2.43 (2.32); 33 2.99 ± 2.42 (2.00); 33 3.30 ± 2.73 (2.49); 35 2.57 ± 2.07 (1.50); 35 * 2.62 ± 1.79 (1.99); 34 1.78 ± 1.06 (1.46); 34 *
Leucocytes
[/nL] (1) (2)
7.46 ± 1.86 (7.19); 39 7.26 ± 1.83 (6.90); 39 7.01 ± 1.65 (6.90); 37 6.01 ± 1.54 (5.90); 37 * 6.94 ± 1.81 (6.63); 37 6.10 ± 1.55 (6.18); 37 *
NFkB
[RLU]
1.248 ± 0.756 (0.785); 38 1.228 ± 0.688 (0.805); 38 1.024 ± 0.630 (0.745); 36 0.992 ± 0.588 (0.705); 36 1.172 ± 0.707 (0.760); 35 1.154 ± 0.703 (0.750); 35
PAI-1
[ng/mL]
71.2 ± 23.5 (70.0); 39 61.2 ± 27.7 (54.4); 39 * 71.4 ± 25.7 (76.3); 37 62.0 ± 29.9 (59.7); 37 * 70.9 ± 27.8 (76.0); 36 53.3 ± 30.4 (54.5); 36 *
Adiponectin
[mg/L] (1) (2)
4.43 ± 2.61 (4.16); 39 4.33 ± 2.34 (4.00); 39 4.29 ± 2.69 (3.85); 37 13.20 ± 8.81 (11.49); 37 * 4.83 ± 3.08 (4.11); 37 13.42 ± 7.69 (10.94); 37 *
E-Selectin
[ng/mL] (1) (2)
47.1 ± 18.7 (45.3); 39 46.5 ± 19.9 (39.2); 39 48.2 ± 17.4 (43.4); 37 43.6 ± 16.2 (38.7); 38 * 45.7 ± 16.7 (43.8); 37 42.0 ± 16.1 (41.2); 37 *
PGFα
[ng/mmol]
164 ± 89
(147); 38
186 ± 99
(168); 38
171 ± 131
(130); 36
186 ± 114
(144); 36
140 ± 46
(133); 37
162 ± 94
(138); 37
Total cholesterol
[mmol/L]
5.02 ± 0.99 (4.90);39 4.82 ± 0.90 (4.90);39 4.80 ± 0.89 (4.56);37 4.89 ± 0.89 (4.86);37 4.71 ± 0.77 (4.68);37 4.87 ± 0.86 (4.59);37
LDL-cholesterol
[mmol/L]
3.21 ± 0.78 (3.11); 38 3.08 ± 0.78 (3.12); 38 3.08 ± 0.72 (2.93); 37 3.10 ± 0.74 (3.01); 37 3.05 ± 0.62 (3.09); 37 3.11 ± 0.68 (3.07); 37
HDL-cholesterol
[mmol/L] (2) (3)
1.24 ± 0.27 (1.30); 38 1.29 ± 0.26 (1.28); 38 1.19 ± 0.39 (1.16); 37 1.29 ± 0.42 (1.17); 37 * 1.19 ± 0.29 (1.18); 37 1.41 ± 0.36 (1.42); 37 *
Triglycerides
[mmol/L]
2.03 ± 2.63 (1.54); 39 1.76 ± 0.70 (1.66); 39 1.76 ± 0.86 (1.50); 37 1.70 ± 1.04 (1.35); 37 1.72 ± 0.80 (1.71); 37 1.54 ± 0.63 (1.52); 37 *
Crea./Albu. Ratio
[mmol/mg]
1.14 ± 0.76 (1.18); 33 1.72 ± 3.12 (0.97); 33 3.47 ± 14.55 (0.88); 33 1.19 ± 1.00 (0.93); 33 * 1.89 ± 3.14 (0.80); 35 1.54 ± 1.61 (0.96); 35
GFR
[ml/min]
114.2 ± 34.2 (104.5); 39 115.8 ± 38.9 (108.7); 39 116.9 ± 33.7 (105.0); 37 115.3 ± 36.6 (106.7); 37 118.7 ± 47.3 (106.0); 37 117.2 ± 47.9 (106.0); 37
Mean insulin dos.; [units] (1) (2) 35.2 ± 17.1 (32.0); 38 37.7 ± 19.6 (35.2); 38 34.5 ± 16.9 (33.0); 35 27.2 ± 14.6 (25.9); 35 35.4 ± 20.3 (32.4); 37 29.4 ± 20.9 (24.2); 37
  1. MET = Metformin; PIO = Pioglitazone; Ln = logarithmic transformation; LOCF = last observation carried forward
  2. a): baseline = values of V2.2 (randomization) or screening as applicable; dos. = dosage
  3. * = p < 0.0307 for within group comparisons
  4. (1) = p < 0.0307 for MET vs. PIO; (2) = p < 0.0307 for MET vs. MET+PIO; (3) = p < 0.0307 for PIO vs. MET+PIO.