Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy
Table 5
Maternal and neonatal characteristics in treatment groups adjusted for BMI ().
Parameters
Normal (BMI ≤ 30),
Obese (BMI > 30),
valued
Group
Mean ± SD
valuea
valueb
valuec
Mean ± SD
valuea
valueb
valuec
Total weight gain in pregnancy (Kg)
<0.01*
Metformin alone
10.53 ± 0.87
0.031*
9.66 ± 2.30
0.664
Metformin + insulin
9.12 ± 1.31
<0.01*
10.82 ± 0.84
0.011*
Insulin alone
11.71 ± 0.95
<0.01*
11.82 ± 0.84
<0.01*
Pharmacotherapeutic characteristics
Insulin: mean dose units/day
0.519
Metformin alone
—
—
—
—
Metformin + insulin
27.63 ± 6.03
—
22.84 ± 3.78
—
Insulin alone
75.52 ± 14.93
<0.01*
78.18 ± 12.06
<0.01*
Mean gestational age when insulin started (weeks)
<0.01*
Metformin alone
—
—
—
—
Metformin + insulin
28.31 ± 1.95
—
26.20 ± 4.06
—
Insulin alone
8.48 ± 2.50
<0.01*
9.84 ± 5.69
<0.01*
Metformin alone
Metformin + insulin
Insulin alone
value
Metformin alone
Metformin + insulin
Insulin alone
value
()
()
()
()
()
()
Maternal characteristics
Pregnancy Induced Hypertension
0.011*
Yes
1 (7.7)
1 (6.2)
5 (23.8)
0.238
0 (0)
20 (27.0)
31 (39.2)
0.035*
No
12 (92.3)
15 (93.8)
16 (76.2)
3 (100)
54 (73.0)
48 (60.8)
Neonatal characteristics
NICU stay
0.249
Yes
7 (53.8)
2 (12.5)
11 (52.4)
0.029*
0 (0)
19 (25.7)
58 (73.4)
<0.01*
No
6 (46.2)
14 (87.5)
10 (47.6)
3 (100)
55 (74.3)
21 (26.6)
Neonatal hypoglycemia
0.699
Yes
4 (30.8)
0 (0)
5 (23.8)
0.066
0 (0)
7 (9.5)
25 (31.6)
<0.01*
No
9 (69.2)
16 (100)
16 (76.2)
3 (100)
67 (90.5)
54 (68.4)
value calculated by using Mann-Whitney testChi-squareFisher Exact test. aComparison between means of metformin alone and metformin + insulin groups. bComparison between means of metformin alone and insulin alone groups. cComparison between means of metformin + insulin and insulin alone groups. dComparison between BMI with parameters only. *Significant level ≤0.05.
