Back to resultsMetformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Metformin
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring Gestational diabetes mellitus, treatment, metformin
Eligibility 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
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin
Insulin
Arm Description
Outcomes
Primary Outcome Measures
Percentage of fetal macrosomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01087866
Brief Title
Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus
Official Title
Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational diabetes mellitus, treatment, metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Title
Insulin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
Percentage of fetal macrosomy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilkka Ijas, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tytti Raudaskoski, MD,PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marja Vaarasmaki, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21083860
Citation
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.
Results Reference
derived
Learn more about this trial
Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus
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