| |
Metformin n = 52
|
Placebo n = 51
|
p value
|
|---|
|
Primary outcome
|
|
First 24 hours
|
n = 47a
|
n = 49a
| |
|
Hyperglycemia episodesb
|
|
Non GDM
|
3.9 ± 1.4
|
4.0 ± 1.7
|
0.81
|
|
GDM
|
3.9 ± 1.5
|
4.4 ± 1.6
|
0.40
|
|
Secondary outcomes
|
|
First 24 hours
|
|
Hypoglycemia episodesc
| | | |
|
Non GDM
|
0.1 ± 0.2
|
0.2 ± 0.5
|
0.23
|
|
GDM
|
0 ± 0
|
0.0 ± 0.0
|
0.48
|
|
Second 24 hours
|
n = 46a
|
n = 40a
| |
|
Hyperglycemia episodesb
|
|
Non GDM
|
1.0 ± 1.3
|
1.1 ± 1.0
|
0.83
|
|
GDM
|
1.5 ± 1.0
|
1.8 ± 1.2
|
0.70
|
|
Hypoglycemia episodesc
|
|
Non GDM
|
0.8 ± 0.9
|
0.6 ± 0.8
|
0.48
|
|
GDM
|
0.4 ± 0.9
|
0.3 ± 0.6
|
0.27
|
|
Third 24 hours
|
n = 37a
|
n = 37a
| |
|
Hyperglycemia episodesb
|
|
Non GDM
|
0.5 ± 1.0
|
0.6 ± 0.8
|
0.94
|
|
GDM
|
0.3 ± 0.7
|
0.7 ± 1.1
|
0.61
|
|
Hypoglycemia episodesc
|
|
Non GDM
|
0.7 ± 0.9
|
0.8 ± 0.8
|
0.37
|
|
vGDM
|
0.9 ± 0.8
|
1.1 ± 0.9
|
0.43
|
|
Blood sugar profile points 4–9
|
|
Hyperglycemic episodes
|
2.7 ± 1.5
|
3.1 ± 1.4
|
0.16
|
| |
3 [2-4]
|
3 [2-4]
|
0.15
|
- Data expressed as mean ± standard deviation and number (%). Analyses by Student t test for comparison of means. P > 0.05 for all analyses
- aNumber of monitoring compliant patients included in analysis: compliance defined as at least four of the six pre or 2-hour post meal sugar capillary blood profile points done in the relevant 24-hour block of the 3-day trial period
- bHyperglycemia is defined as pre meal blood glucose level of ≥ 5.3 mmol/L and 2 hours post prandial/meal blood glucose of ≥ 6.7 mmol/L
- cHypoglycemia is defined as capillary blood glucose level ≤ 3.9 mmol/L
