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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.
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Cardiovascular Diabetology

ISSN: 1475-2840