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Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

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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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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     History of Changes
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
 Insulin
Insulin, Globin Zinc
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs