Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

NCT ID: NCT01087866

Last Updated: 2010-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to determine if metformin therapy prevents fetal macrosomy in gestational diabetes mellitus to the same extent as insulin therapy.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Insulin

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Insulin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* gestational diabetes mellitus diagnosed between 12-34 pregnancy weeks if normoglycemia is not reached with diet

Exclusion Criteria

* hypertension with pharmacological treatment or preeclampsia
* multiple pregnancy
* liver or kidney disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Dept. Obstetrics and Gynecology, Oulu University Hospital

Principal Investigators

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Hilkka Ijas, MD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Tytti Raudaskoski, MD,PhD

Role: STUDY_DIRECTOR

Oulu University Hospital

Marja Vaarasmaki, MD, PhD

Role: STUDY_CHAIR

Oulu University Hospital

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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Ijas H, Vaarasmaki M, Morin-Papunen L, Keravuo R, Ebeling T, Saarela T, Raudaskoski T. Metformin should be considered in the treatment of gestational diabetes: a prospective randomised study. BJOG. 2011 Jun;118(7):880-5. doi: 10.1111/j.1471-0528.2010.02763.x. Epub 2010 Nov 18.

Reference Type DERIVED
PMID: 21083860 (View on PubMed)

Other Identifiers

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070471

Identifier Type: -

Identifier Source: org_study_id

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