Metformin Versus Insulin in Gestational Diabetes

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Gestational Diabetes

Treatments: Drug: metformin; Drug: insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01240785

246/2005

Details and patient eligibility

About

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).

Full description

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). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.

Enrollment: 221 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

1. Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
2. Renal, hepatic or cardiac failure
3. Pregestational use of metformin
4. Pregnancy with multiple fetuses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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221 participants in 2 patient groups

Metformin

Active Comparator group

Description:

Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values

Treatment:

Drug: metformin

insulin

Active Comparator group

Description:

NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values

Treatment:

Drug: insulin