Your session is about to expire
← Back to Search
Sodium-glucose cotransporter 2 (SGLT2) inhibitor
Empagliflozin for Gestational Diabetes (EMPA post-GDM Trial)
Phase 3
Recruiting
Led By Caroline kramer, MD PhD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 20 - 50 years inclusive
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48-weeks
Awards & highlights
EMPA post-GDM Trial Summary
This trial will compare the effects of a diabetes drug to placebo in women who had gestational diabetes.
Who is the study for?
This trial is for non-breastfeeding women aged 20-50 who had gestational diabetes and are 6-36 months postpartum. They must not be pregnant, planning pregnancy, or have significant liver disease, hypersensitivity to the drug tested, recurrent urinary infections, severe kidney issues, current diabetes treatment or a history of diabetic ketoacidosis.Check my eligibility
What is being tested?
The study tests if Empagliflozin helps preserve beta-cell function in women with past gestational diabetes. It's a double-blind trial where participants randomly receive either Empagliflozin or a placebo for 48 weeks. Beta-cell function is measured at different intervals using an oral glucose tolerance test.See study design
What are the potential side effects?
Potential side effects of Empagliflozin include urinary tract infections due to increased sugar in urine which bacteria feed on; dehydration since it causes the body to expel more water; and possible allergic reactions if sensitive to the medication.
EMPA post-GDM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 50 years old.
EMPA post-GDM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Baseline-adjusted ISSI-2 at 48-weeks
Secondary outcome measures
Glucose tolerance status at 48-weeks
Other outcome measures
Baseline-adjusted insulinogenic index/HOMA-IR at 48-weeks
Baseline-adjusted ΔISR0-120/Δgluc0-120 × Matsuda index at 48 weeks
Body mass index at 48-weeks
+3 moreSide effects data
From 2019 Phase 2 trial • 80 Patients • NCT0320086038%
Renal/Urinary
33%
Musculoskeletal
23%
Cardiovascular
23%
Metabolic
15%
Other
15%
Gastrointestinal
8%
Worsening Heart Failure
8%
Respiratory
3%
Angioedema
3%
Acute Kidney Injury
3%
S. Aureus Bacteremia
3%
Worsening Renal Function
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
Placebo
EMPA post-GDM Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EmpagliflozinExperimental Treatment1 Intervention
Empagliflozin 10 mg PO daily
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo PO daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
FDA approved
Find a Location
Who is running the clinical trial?
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,488 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,787 Total Patients Enrolled
Caroline kramer, MD PhDPrincipal InvestigatorMOUNT SINAI HOSPITAL
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant liver issues, such as jaundice, chronic hepatitis, or a liver transplant.I have had cancer treatment other than for basal cell skin cancer in the last 5 years.I have had more than 2 urinary infections in the last year.My kidney function is low, with a filtration rate under 45 ml/min.I have diabetes or am taking medication for diabetes.You are allergic to empagliflozin or any forms of this medicine.I am not pregnant and willing to use effective birth control during and 3 months after the study.I have had diabetic ketoacidosis in the past.I had gestational diabetes, am 6-36 months postpartum, and am not breastfeeding.You need to have a negative pregnancy test when you join the study.I am between 20 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Empagliflozin
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger