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NCT00414245 Clinical Trial

Metformin for the Treatment of Diabetes in Pregnancy

Gestational Diabetes Clinical Trial

Official title:
Metformin for the Treatment of Diabetes in Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00414245
Other study ID # sor434306ctil
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received December 20, 2006
Last updated December 20, 2006
Start date January 2007

Study information
Verified date December 2006
Source Soroka University Medical Center
Contact Boaz Sheizaf, MD
Phone 972-54-2401191
Email bsheizaf@bgu.ac.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- pregnant women

- GDM A2

- diabetes mellitus type 2

- singleton pregnancy

Exclusion Criteria:

- diabetic nephropathy or proliferative retinopathy

- cannot swallow tablets

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• metformin

Locations
Country Name City State
Israel Division of Obstetrics and Gynecology, Soroka University Medical Center Beer-Sheva

Sponsors (2)
Lead Sponsor Collaborator
Soroka University Medical Center Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary glycemic control
Primary pregnancy complications
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