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Metformin Versus Insulin in Gestational Diabetes

NCT01240785 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2014-11-24

Study results available
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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).

Conditions

  • Gestational Diabetes

Interventions

DRUG

metformin

metformin 1 g twice daily or maximum tolerated dose less than 2 g daily

DRUG

insulin

subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Tapani Rönnemaa, MD, PhD · Professor, Chief Physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-01-31
Completion
2012-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01240785 on ClinicalTrials.gov