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Biguanide
Metformin for Preventing Type 2 Diabetes After Gestational Diabetes
Phase 3
Waitlist Available
Led By Erika Werner, MD
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Study Summary
This trial is testing whether the diabetes drug metformin can also help prevent the disease in women who have had gestational diabetes.
Who is the study for?
This trial is for women over 18 who had gestational diabetes and are delivering at Tufts Medical Center. They must have opted for a specific glucose test postpartum and be able to consent. Women already on metformin, with liver disease, heart failure, or other conditions affecting glucose metabolism can't join.Check my eligibility
What is being tested?
The study tests if taking metformin daily for a year after giving birth helps prevent type 2 diabetes in those who had gestational diabetes, compared to the usual diet and lifestyle advice.See study design
What are the potential side effects?
Metformin may cause side effects like nausea, diarrhea, stomach pain, or loss of appetite. It's generally well-tolerated but can rarely lead to vitamin B12 deficiency or affect kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HbA1C
Secondary outcome measures
Weight
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: MetforminExperimental Treatment1 Intervention
Participants will be given a daily prescription of metformin for 12 months postpartum. At 12 months and again at 15 months (3 months off the drug), HbA1c and weight will be assessed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
255 Previous Clinical Trials
255,238 Total Patients Enrolled
Erika Werner, MDPrincipal InvestigatorTufts Medical Center
1 Previous Clinical Trials
540 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have been diagnosed with congestive heart failure.I have diabetes.Chose to have the 2-hour 75-gram oral glucose tolerance test (OGTT) while in the hospital after giving birth.I am not on medication that affects metformin breakdown.I am on long-term medication for a chronic condition that affects my blood sugar.My kidney function is impaired.I am currently taking metformin and I am not pregnant.I have a liver condition.You had diabetes during pregnancy.I cannot take metformin due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Metformin for public consumption?
"Metformin's safety is well-documented, as it has been studied in numerous Phase 3 clinical trials. This drug receives a score of 3."
Answered by AI
How many people are researchers working with in this experiment?
"That is correct, the online clinicaltrials.gov registry currently lists this trial as open and recruiting patients. This trial was originally posted on 6/1/2022 and was most recently edited on 8/11/2022. A total of 36 patients will be enrolled at 1 site."
Answered by AI
Are people with the target illness able to sign up for this experiment right now?
"Yes, this trial is still open to patients and recruiting at a single site. The original posting date was June 1st, 2022, with the most recent update on August 11th, 2022. So far, the study has enrolled 36 patients."
Answered by AI
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