search
Back to results

Metformin for the Treatment of Diabetes in Pregnancy

Primary Purpose

Gestational Diabetes, Diabetes Mellitus Type 2

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
metformin
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pregnant women
  • GDM A2
  • diabetes mellitus type 2
  • singleton pregnancy

Exclusion Criteria:

  • diabetic nephropathy or proliferative retinopathy
  • cannot swallow tablets

Sites / Locations

  • Division of Obstetrics and Gynecology, Soroka University Medical Center

Outcomes

Primary Outcome Measures

glycemic control
pregnancy complications

Secondary Outcome Measures

Full Information

First Posted
December 20, 2006
Last Updated
December 20, 2006
Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev
search

1. Study Identification

Unique Protocol Identification Number
NCT00414245
Brief Title
Metformin for the Treatment of Diabetes in Pregnancy
Official Title
Metformin for the Treatment of Diabetes in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
metformin
Primary Outcome Measure Information:
Title
glycemic control
Title
pregnancy complications

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pregnant women GDM A2 diabetes mellitus type 2 singleton pregnancy Exclusion Criteria: diabetic nephropathy or proliferative retinopathy cannot swallow tablets
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boaz Sheizaf, MD
Phone
972-54-2401191
Email
bsheizaf@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boaz Sheizaf, MD
Organizational Affiliation
division of obstetrics and gynecology, soroka university medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Obstetrics and Gynecology, Soroka University Medical Center
City
Beer-Sheva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boaz Sheizaf, MD
Phone
972-54-2401191
Email
bsheizaf@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Boaz Sheizaf, MD

12. IPD Sharing Statement

Learn more about this trial

Metformin for the Treatment of Diabetes in Pregnancy

We'll reach out to this number within 24 hrs