Gestational DiabetesPhase 3NCT04615351
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
A Phase 3 study testing Metformin in people with Gestational Diabetes, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
A Pilot of Metformin Postpartum Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 30 Jun 2022
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational Diabetes
Who cannot join
- Cannot tolerate metformin
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Women & Infants Hospital
Providence, Rhode Island, 02905
Erika F Werner, MD, 401-274-1122, ewerner@wihri.org
About this study
A Pilot of Metformin Postpartum
Read the detailed description
The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history of GDM.
- Conditions
- Gestational Diabetes
- Being tested
- Metformin
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Medication
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin 500 mg to be taken twice per day for two weeks and then metformin 1000 mg PO twice daily after tolerating the lower dose Receives: Drug: Metformin |
| Routine Care | No intervention | Discharge information about maintaining a healthy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediabetes or Diabetes
glycosylated hemoglobin (HgbA1c) at 1 year postpartum (>/= 5.7% defined as prediabetes, >/=6.5% defined as DM
Measured: 1 year postpartum
Secondary outcomes (1)
Prediabetes or diabetes at 15 months postpartum
HgbA1c at 15 months postpartum
Measured: 15 months after delivery and study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start15 Nov 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615351
- Sponsor's protocol ID
- 1248906-9
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04615351
- Acronym / sponsor ID
- 1248906-9
- Conditions
- Gestational Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Nov 2020 (actual)
- 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.
A Pilot of Metformin Postpartum
Detailed description
The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history of GDM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminMetformin 500 mg to be taken twice per day for two weeks and then metformin 1000 mg PO twice daily after tolerating the lower dose |
| Routine Care | No intervention | –Discharge information about maintaining a healthy diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Gestational Diabetes
Key exclusion criteria (1 listed)
- Cannot tolerate metformin
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 |
|---|---|---|
| MetforminMedication | Drug | Metformin |
Primary outcome
Prediabetes or Diabetes
Time frame: 1 year postpartum
glycosylated hemoglobin (HgbA1c) at 1 year postpartum (>/= 5.7% defined as prediabetes, >/=6.5% defined as DM
1 secondary outcome
Prediabetes or diabetes at 15 months postpartum
Time frame: 15 months after delivery and study initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: Yes
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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.
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, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
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 1 inclusion and 1 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 4 Nov 2020. 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 United States. 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 Donna Allard (4012741122, dallard@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediabetes or Diabetes (time frame: 1 year postpartum). 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 4 Nov 2020.