Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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Metformin for the Treatment of Diabetes in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00414245
First received: December 20, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Gestational Diabetes
Diabetes Mellitus Type 2
 Drug: metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metformin for the Treatment of Diabetes in Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • glycemic control
  • pregnancy complications
Estimated Enrollment: 200
Study Start Date: January 2007
  Eligibility
Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetic nephropathy or proliferative retinopathy
  • cannot swallow tablets
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414245

Contacts
Contact: Boaz Sheizaf, MD 972-54-2401191 bsheizaf@bgu.ac.il

Locations
Israel
Division of Obstetrics and Gynecology, Soroka University Medical Center Not yet recruiting
Beer-Sheva, Israel
Contact: Boaz Sheizaf, MD    972-54-2401191    bsheizaf@bgu.ac.il   
Principal Investigator: Boaz Sheizaf, MD         
Sponsors and Collaborators
Soroka University Medical Center
Ben-Gurion University of the Negev
Investigators
Principal Investigator: Boaz Sheizaf, MD division of obstetrics and gynecology, soroka university medical center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00414245     History of Changes
Other Study ID Numbers: sor434306ctil
Study First Received: December 20, 2006
Last Updated: December 20, 2006
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Pregnancy in Diabetics
Endocrine System Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Pregnancy Complications
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015