Metformin for the Treatment of Diabetes in Pregnancy
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy. |
|---|---|
| Condition | Gestational Diabetes Diabetes Mellitus Type 2 |
| Intervention | Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Soroka University Medical Center |
| Responsible Party | Soroka University Medical Center |
| ClinicalTrials.gov Identifier | NCT00414245 |
| First Received | December 20, 2006 |
| Last Updated | December 20, 2006 |
| Last verified | December 2006 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 20, 2006 |
|---|---|
| Last Updated Date | December 20, 2006 |
| Start Date | January 2007 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin for the Treatment of Diabetes in Pregnancy |
|---|---|
| Official Title | Metformin for the Treatment of Diabetes in Pregnancy |
| Brief Summary | The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - pregnant women - GDM A2 - diabetes mellitus type 2 - singleton pregnancy Exclusion Criteria: - diabetic nephropathy or proliferative retinopathy - cannot swallow tablets |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Boaz Sheizaf, MD 972-54-2401191 bsheizaf@bgu.ac.il |
| Location Countries | Israel |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00414245 |
|---|---|
| Other Study ID Numbers | sor434306ctil |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Soroka University Medical Center |
| Study Sponsor | Soroka University Medical Center |
| Collaborators | Ben-Gurion University of the Negev |
| Investigators | Principal Investigator: Boaz Sheizaf, MD division of obstetrics and gynecology, soroka university medical center |
| Verification Date | December 2006 |
Locations[ + expand ][ + ]
| Division of Obstetrics and Gynecology, Soroka University Medical Center | Beer-Sheva, Israel Contact: Boaz Sheizaf, MD | 972-54-2401191 | bsheizaf@bgu.ac.ilPrincipal Investigator: Boaz Sheizaf, MD Not yet recruiting |
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