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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
Must not have
Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5X the upper limit of normal
Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48-weeks
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 20 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant liver issues, such as jaundice, chronic hepatitis, or a liver transplant.
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I have had cancer treatment other than for basal cell skin cancer in the last 5 years.
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I have had more than 2 urinary infections in the last year.
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My kidney function is low, with a filtration rate under 45 ml/min.
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I have diabetes or am taking medication for diabetes.
Select...
I have had diabetic ketoacidosis in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline-adjusted ISSI-2 at 48-weeks
Secondary study objectives
Glucose tolerance status at 48-weeks
Other study objectives
Baseline-adjusted insulinogenic index/HOMA-IR at 48-weeks
Baseline-adjusted ΔISR0-120/Δgluc0-120 × Matsuda index at 48 weeks
Central abdominal fat mass at 48 weeks
+2 more

Side effects data

From 2019 Phase 2 trial • 80 Patients • NCT03200860
38%
Renal/Urinary
33%
Musculoskeletal
23%
Cardiovascular
23%
Metabolic
15%
Gastrointestinal
15%
Other
8%
Worsening Heart Failure
8%
Respiratory
3%
Worsening Renal Function
3%
S. Aureus Bacteremia
3%
Angioedema
3%
Acute Kidney Injury
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Empagliflozin

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
204 Previous Clinical Trials
69,077 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,554 Previous Clinical Trials
15,897,175 Total Patients Enrolled
Caroline kramer, MD PhDPrincipal InvestigatorMOUNT SINAI HOSPITAL

Media Library

Empagliflozin 10 MG (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03215069 — Phase 3
Gestational Diabetes Research Study Groups: Placebo, Empagliflozin
Gestational Diabetes Clinical Trial 2023: Empagliflozin 10 MG Highlights & Side Effects. Trial Name: NCT03215069 — Phase 3
Empagliflozin 10 MG (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03215069 — Phase 3
~16 spots leftby Dec 2025
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