NCT01087866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

Enrollment Period

4.2 years

First QC Date

March 15, 2010

Last Update Submit

March 15, 2010

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational diabetes mellitustreatmentmetformin

Outcome Measures

Primary Outcomes (1)

  • Percentage of fetal macrosomy

Study Arms (2)

Metformin

EXPERIMENTAL
Drug: Metformin

Insulin

ACTIVE COMPARATOR
Drug: Insulin

Interventions

MetforminDRUG
Metformin
InsulinDRUG
Insulin

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • hypertension with pharmacological treatment or preeclampsia
  • multiple pregnancy
  • liver or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

Location

Related Publications (1)

  • 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.

    PMID: 21083860DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

MetforminInsulin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Hilkka Ijas, MD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

  • Tytti Raudaskoski, MD,PhD

    Oulu University Hospital

    STUDY DIRECTOR

  • Marja Vaarasmaki, MD, PhD

    Oulu University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 16, 2010

Study Start

June 1, 2005

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

March 16, 2010

Record last verified: 2010-03

Locations

FI(1)