Gestational DiabetesPhase 3NCT00414245
Metformin for the Treatment of Diabetes in Pregnancy
A Phase 3 study testing metformin in people with Gestational Diabetes and Diabetes Mellitus Type 2, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Diabetes Mellitus Type 2
- What is being tested?
- metformin
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women
- GDM A2
- diabetes mellitus type 2
- singleton pregnancy
Who cannot join
- diabetic nephropathy or proliferative retinopathy
- cannot swallow tablets
Trial locations and contacts
1 site in 1 country.
Israel1 site
Division of Obstetrics and Gynecology, Soroka University Medical Center
Beersheba
Boaz Sheizaf, MD, 972-54-2401191, bsheizaf@bgu.ac.il
Boaz Sheizaf, MD
About this study
The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy.
- Conditions
- Gestational Diabetes, Diabetes Mellitus Type 2
- Being tested
- metformin
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
pregnancy complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Investigators
- Boaz Sheizaf, MD, Principal investigator, division of obstetrics and gynecology, soroka university medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414245
- Sponsor's protocol ID
- sor434306ctil
- Status last verified
- Dec 2006
- First submitted
- 20 Dec 2006
- Last updated
- 21 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin for the Treatment of Diabetes in Pregnancy
- ClinicalTrials.gov ID
- NCT00414245
- Acronym / sponsor ID
- sor434306ctil
- Conditions
- Gestational Diabetes, Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Jan 2007
- First posted
- 21 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- pregnant women
- GDM A2
- diabetes mellitus type 2
- singleton pregnancy
Key exclusion criteria (2 listed)
- diabetic nephropathy or proliferative retinopathy
- cannot swallow tablets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metformin | Drug | – |
Primary outcome
glycemic control
pregnancy complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2006.
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boaz Sheizaf, MD principal investigator
division of obstetrics and gynecology, soroka university medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing metformin in people with Gestational Diabetes and Diabetes Mellitus Type 2, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boaz Sheizaf, MD (972-54-2401191, bsheizaf@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic control. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2006.