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Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087866
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
University of Oulu

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Drug: Metformin Drug: Insulin Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study
Study Start Date : June 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Metformin Drug: Metformin
Active Comparator: Insulin Drug: Insulin


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of fetal macrosomy

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087866


Locations
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Finland
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Investigators
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Principal Investigator: Hilkka Ijas, MD Oulu University Hospital
Study Director: Tytti Raudaskoski, MD,PhD Oulu University Hospital
Study Chair: Marja Vaarasmaki, MD, PhD Oulu University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ijas Hilkka, MD, Dept. Obstetrics and Gynecology, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT01087866    
Other Study ID Numbers: 070471
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by University of Oulu:
Gestational diabetes mellitus
treatment
metformin
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs