Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE, for the Sitagliptin 036 Study Group: Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care 30:1979–1987, 2007
In Table 2 of the article above, an asterisk was missing denoting a significant difference between the 1,000 mg metformin b.i.d. group and placebo. The corrected table appears on the following page. The online version reflects these changes.
Efficacy end points following a meal tolerance test
Parameter . | Placebo . | Sitagliptin 100 mg q.d. . | Metformin 500 mg b.i.d. . | Metformin 1,000 mg b.i.d. . | Sitagliptin 50 mg + metformin 500 mg b.i.d. . | Sitagliptin 50 mg + metformin 1,000 mg b.i.d. . |
---|---|---|---|---|---|---|
2-h PPG (mg/dl) | ||||||
n | 129 | 136 | 141 | 138 | 147 | 152 |
Baseline | 276.8 ± 66.7 | 285.4 ± 82.8 | 292.7 ± 74.6 | 283.4 ± 81.8 | 291.8 ± 84.6 | 286.9 ± 76.2 |
Week 24 | 281.3 ± 88.2 | 233.8 ± 89.5 | 236.3 ± 70.8 | 207.0 ± 69.4 | 196.3 ± 72.5 | 170.3 ± 58.6 |
Change from baseline | 0.3 (−10.4 to 11.0) | −51.9 (−62.3 to −41.5) | −53.4 (−63.6 to −43.2) | −78.0 (−88.3 to −67.6) | −92.5 (−102.6 to −82.5) | −116.6 (−126.4 to −106.7) |
Change from placebo | — | −52.2 (−67.1 to −37.3)* | −53.7 (−68.5 to −38.9)* | −78.3 (−93.1 to −63.4)* | −92.8 (−107.5 to −78.1)*† | −116.9 (−131.4 to −102.3)*† |
Glucose AUC (mg · h−1 · dl−1) | ||||||
n | 127 | 133 | 144 | 137 | 149 | 146 |
Baseline | 523.0 ± 109.4 | 530.2 ± 123.9 | 538.4 ± 116.0 | 532.1 ± 125.6 | 539.9 ± 136.7 | 530.0 ± 120.7 |
Week 24 | 533.3 ± 146.9 | 453.2 ± 135.3 | 451.3 ± 118.4 | 401.7 ± 120.4 | 383.9 ± 114.0 | 339.0 ± 100.4 |
Change from baseline | 6.1 (−11.7 to 23.9) | −78.0 (−95.4 to −60.6) | −84.4 (−101.1 to −67.7) | −130.8 (−147.9 to −113.6) | −152.4 (−168.9 to −136.0) | −192.3 (−209.0 to −175.7) |
Change from placebo | — | −84.2 (−109.1 to −59.3)* | −90.5 (−115.5 to −66.1)* | −136.9 (−161.6 to −112.2)* | −158.6 (−182.8 to −134.3)*† | −198.5 (−222.8 to −174.1)*† |
Insulin AUC (μIU · h−1 · ml−1) | ||||||
n | 119 | 117 | 130 | 125 | 126 | 133 |
Baseline | 76.5 ± 52.9 | 71.2 ± 50.2 | 80.1 ± 56.4 | 84.3 ± 53.6 | 79.0 ± 57.2 | 74.9 ± 47.2 |
Week 24 | 75.0 ± 50.3 | 78.1 ± 49.3 | 83.1 ± 54.6 | 82.2 ± 51.4 | 86.3 ± 55.7 | 74.5 ± 40.6 |
Change from baseline | −1.8 (−7.5 to 3.9) | 5.2 (−0.6 to 11.0) | 3.6 (−1.9 to 9.1) | −0.4 (−6.0 to 5.2) | 7.5 (2.0–13.1) | −1.1 (−6.5 to 4.4) |
Change from placebo | — | 7.0 (−1.2 to 15.1) | 5.4 (−2.5 to 13.3) | 1.4 (−6.6 to 9.4) | 9.4 (1.4–17.3)‡ | 0.7 (−7.1 to 8.6) |
C-peptide AUC (ng · h−1 · ml−1) | 125 | 135 | 143 | 138 | 146 | 145 |
n | ||||||
Baseline | 9.8 ± 4.3 | 9.8 ± 4.3 | 10.3 ± 4.1 | 10.9 ± 4.3 | 9.9 ± 4.3 | 10.1 ± 4.1 |
Week 24 | 9.8 ± 4.2 | 10.5 ± 4.0 | 10.2 ± 4.1 | 10.6 ± 4.1 | 10.6 ± 4.1 | 10.4 ± 4.1 |
Change from baseline | −0.1 (−0.5 to 0.3) | 0.6 (0.2–1.0) | 0.0 (−0.4 to 0.4) | −0.1 (−0.5 to 0.3) | 0.6 (0.2–1.0) | 0.3 (−0.1 to 0.7) |
Change from placebo | — | 0.7 (0.1–1.3)‡ | 0.1 (−0.5 to 0.7) | 0.0 (−0.6 to 0.6) | 0.7 (0.1–1.3)‡§ | 0.4 (−0.2 to 1.0) |
Insulin AUC/glucose AUC | 117 | 115 | 128 | 121 | 125 | 130 |
n | ||||||
Baseline | 0.16 ± 0.14 | 0.15 ± 0.12 | 0.16 ± 0.12 | 0.18 ± 0.15 | 0.16 ± 0.14 | 0.16 ± 0.12 |
Week 24 | 0.16 ± 0.14 | 0.19 ± 0.13 | 0.20 ± 0.15 | 0.23 ± 0.17 | 0.24 ± 0.17 | 0.23 ± 0.14 |
Change from baseline | 0.00 (−0.02 to 0.02) | 0.04 (0.02–0.05) | 0.04 (0.02–0.06) | 0.05 (0.03–0.07) | 0.08 (0.06–0.10) | 0.08 (0.06–0.09) |
Change from placebo | — | 0.03 (0.01–0.06)‡ | 0.04 (0.01–0.06)‡ | 0.05 (0.02–0.07)* | 0.08 (0.05–0.10)*† | 0.07 (0.05–0.10)*‖ |
Parameter . | Placebo . | Sitagliptin 100 mg q.d. . | Metformin 500 mg b.i.d. . | Metformin 1,000 mg b.i.d. . | Sitagliptin 50 mg + metformin 500 mg b.i.d. . | Sitagliptin 50 mg + metformin 1,000 mg b.i.d. . |
---|---|---|---|---|---|---|
2-h PPG (mg/dl) | ||||||
n | 129 | 136 | 141 | 138 | 147 | 152 |
Baseline | 276.8 ± 66.7 | 285.4 ± 82.8 | 292.7 ± 74.6 | 283.4 ± 81.8 | 291.8 ± 84.6 | 286.9 ± 76.2 |
Week 24 | 281.3 ± 88.2 | 233.8 ± 89.5 | 236.3 ± 70.8 | 207.0 ± 69.4 | 196.3 ± 72.5 | 170.3 ± 58.6 |
Change from baseline | 0.3 (−10.4 to 11.0) | −51.9 (−62.3 to −41.5) | −53.4 (−63.6 to −43.2) | −78.0 (−88.3 to −67.6) | −92.5 (−102.6 to −82.5) | −116.6 (−126.4 to −106.7) |
Change from placebo | — | −52.2 (−67.1 to −37.3)* | −53.7 (−68.5 to −38.9)* | −78.3 (−93.1 to −63.4)* | −92.8 (−107.5 to −78.1)*† | −116.9 (−131.4 to −102.3)*† |
Glucose AUC (mg · h−1 · dl−1) | ||||||
n | 127 | 133 | 144 | 137 | 149 | 146 |
Baseline | 523.0 ± 109.4 | 530.2 ± 123.9 | 538.4 ± 116.0 | 532.1 ± 125.6 | 539.9 ± 136.7 | 530.0 ± 120.7 |
Week 24 | 533.3 ± 146.9 | 453.2 ± 135.3 | 451.3 ± 118.4 | 401.7 ± 120.4 | 383.9 ± 114.0 | 339.0 ± 100.4 |
Change from baseline | 6.1 (−11.7 to 23.9) | −78.0 (−95.4 to −60.6) | −84.4 (−101.1 to −67.7) | −130.8 (−147.9 to −113.6) | −152.4 (−168.9 to −136.0) | −192.3 (−209.0 to −175.7) |
Change from placebo | — | −84.2 (−109.1 to −59.3)* | −90.5 (−115.5 to −66.1)* | −136.9 (−161.6 to −112.2)* | −158.6 (−182.8 to −134.3)*† | −198.5 (−222.8 to −174.1)*† |
Insulin AUC (μIU · h−1 · ml−1) | ||||||
n | 119 | 117 | 130 | 125 | 126 | 133 |
Baseline | 76.5 ± 52.9 | 71.2 ± 50.2 | 80.1 ± 56.4 | 84.3 ± 53.6 | 79.0 ± 57.2 | 74.9 ± 47.2 |
Week 24 | 75.0 ± 50.3 | 78.1 ± 49.3 | 83.1 ± 54.6 | 82.2 ± 51.4 | 86.3 ± 55.7 | 74.5 ± 40.6 |
Change from baseline | −1.8 (−7.5 to 3.9) | 5.2 (−0.6 to 11.0) | 3.6 (−1.9 to 9.1) | −0.4 (−6.0 to 5.2) | 7.5 (2.0–13.1) | −1.1 (−6.5 to 4.4) |
Change from placebo | — | 7.0 (−1.2 to 15.1) | 5.4 (−2.5 to 13.3) | 1.4 (−6.6 to 9.4) | 9.4 (1.4–17.3)‡ | 0.7 (−7.1 to 8.6) |
C-peptide AUC (ng · h−1 · ml−1) | 125 | 135 | 143 | 138 | 146 | 145 |
n | ||||||
Baseline | 9.8 ± 4.3 | 9.8 ± 4.3 | 10.3 ± 4.1 | 10.9 ± 4.3 | 9.9 ± 4.3 | 10.1 ± 4.1 |
Week 24 | 9.8 ± 4.2 | 10.5 ± 4.0 | 10.2 ± 4.1 | 10.6 ± 4.1 | 10.6 ± 4.1 | 10.4 ± 4.1 |
Change from baseline | −0.1 (−0.5 to 0.3) | 0.6 (0.2–1.0) | 0.0 (−0.4 to 0.4) | −0.1 (−0.5 to 0.3) | 0.6 (0.2–1.0) | 0.3 (−0.1 to 0.7) |
Change from placebo | — | 0.7 (0.1–1.3)‡ | 0.1 (−0.5 to 0.7) | 0.0 (−0.6 to 0.6) | 0.7 (0.1–1.3)‡§ | 0.4 (−0.2 to 1.0) |
Insulin AUC/glucose AUC | 117 | 115 | 128 | 121 | 125 | 130 |
n | ||||||
Baseline | 0.16 ± 0.14 | 0.15 ± 0.12 | 0.16 ± 0.12 | 0.18 ± 0.15 | 0.16 ± 0.14 | 0.16 ± 0.12 |
Week 24 | 0.16 ± 0.14 | 0.19 ± 0.13 | 0.20 ± 0.15 | 0.23 ± 0.17 | 0.24 ± 0.17 | 0.23 ± 0.14 |
Change from baseline | 0.00 (−0.02 to 0.02) | 0.04 (0.02–0.05) | 0.04 (0.02–0.06) | 0.05 (0.03–0.07) | 0.08 (0.06–0.10) | 0.08 (0.06–0.09) |
Change from placebo | — | 0.03 (0.01–0.06)‡ | 0.04 (0.01–0.06)‡ | 0.05 (0.02–0.07)* | 0.08 (0.05–0.10)*† | 0.07 (0.05–0.10)*‖ |
Data are means ± SD for baseline and week 24 and least-squares mean change (95% CI) for change from baseline or placebo.
P ≤ 0.001 for the between-group difference relative to placebo.
P ≤ 0.001 for the between-group difference comparing coadministration and its respective components.
P ≤ 0.05 for the between-group difference relative to placebo.
P < 0.05 for the between-group difference comparing coadministration and metformin 500 mg b.i.d.
P ≤ 0.05 for the between-group difference comparing coadministration and its respective components. AUC, area under the curve; PPG, postprandial plasma glucose.