Phase 4
N=221
Metformin Versus Insulin in Gestational Diabetes
Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01240785 ↗Enrolled (actual)
221
Serious AEs
0.5%
Results posted
Nov 2014
Primary outcome: Primary: Birth Weight Per Arm — 3604; 3589 g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- metformin (Drug); insulin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Turku University Hospital
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Birth Weight Per Arm |
3604; 3589 | — |
| SECONDARY Pregnancy Induced Hypertension Per Arm |
2; 4 | — |
| SECONDARY Maternal Weight Gain Per Arm |
8.0; 7.9 | — |
| SECONDARY Pre-eclampsia Per Arm |
5; 10 | — |
| SECONDARY Mode of Delivery Per Arm |
15; 18 | — |
| SECONDARY Gestational Weeks at Delivery Per Arm |
39.2; 39.3 | — |
| SECONDARY Induction of Delivery Per Arm |
42; 58 | — |
| SECONDARY Shoulder Dystocia Per Arm |
1; 2 | — |
| SECONDARY Neonatal Hypoglycemia Per Arm |
18; 18 | — |
| SECONDARY Neonatal Hyperbilirubinemia Per Arm |
9; 10 | — |
| SECONDARY Apgar Score at 5 Min After Delivery Per Arm |
8.7; 8.9 | — |
| SECONDARY Neonate Transfer to Intensive Care Unit Per Arm |
34; 39 | — |
| SECONDARY Child Outcome at 2 Years Per Arm |
— | — |
Summary
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).
Eligibility Criteria
Inclusion Criteria
- Mothers with gestational diabetes who had at least twice plasma glucose at fasting > 5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks
Exclusion Criteria
- Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
- Renal, hepatic or cardiac failure
- Pregestational use of metformin
- Pregnancy with multiple fetuses
Data sourced from ClinicalTrials.gov (NCT01240785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.