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SGLT2 Inhibitor

Ertugliflozin for Cardiovascular Disease

Phase < 1
Waitlist Available
Led By Tracey McLaughlin, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time to collect tissue collected during surgery (up to 15 minutes)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a medication can help improve heart health by reducing inflammation and making fat cells more sensitive to insulin.

Who is the study for?
This trial is for people with Type 2 Diabetes who are either on metformin or managing their diabetes through diet. They must be scheduled for cardiac bypass surgery at the Stanford Cardiovascular Surgery clinic. Individuals allergic to the study drugs or taking other anti-diabetic medications besides metformin cannot participate.
What is being tested?
The study is testing whether Ertugliflozin, a drug that inhibits SGLT2, can improve heart fat's health by increasing its metabolic flexibility, insulin sensitivity, and reducing cell size and inflammation compared to Glipizide in patients with cardiovascular issues.
What are the potential side effects?
Ertugliflozin may cause dehydration, low blood pressure, kidney problems, increased cholesterol levels, yeast infections and urinary tract infections. Glipizide could lead to hypoglycemia (low blood sugar), weight gain, skin reactions and gastrointestinal disturbances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time to collect tissue collected during surgery (up to 15 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time to collect tissue collected during surgery (up to 15 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples.
Secondary study objectives
Average insulin mediated glucose uptake (IMGU) to measure insulin sensitivity in epicardial adipose tissue samples.
Characterization of the inflammatory cytokine expression profile in epicardial adipose tissue samples.
Distribution of adipose cell size in epicardial tissue.

Side effects data

From 2016 Phase 3 trial • 291 Patients • NCT02226003
5%
Urinary tract infection
3%
Blood glucose increased
1%
Toxicity to various agents
1%
Spinal column stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin 15 mg + Sitagliptin 100 mg
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ErtugliflozinExperimental Treatment1 Intervention
Ertugliflozin, also known as Steglatro, will be administered once daily for 5 days at a dose of 15mg orally.
Group II: GlipizideActive Control1 Intervention
Glipizide will be randomized to either 2.5mg or 5mg oral dose once daily for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ertugliflozin
2010
Completed Phase 3
~8940

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,781 Total Patients Enrolled
7 Trials studying Insulin Resistance
976 Patients Enrolled for Insulin Resistance
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,192 Total Patients Enrolled
30 Trials studying Insulin Resistance
2,566 Patients Enrolled for Insulin Resistance
Tracey McLaughlin, MDPrincipal InvestigatorStanford University
10 Previous Clinical Trials
764 Total Patients Enrolled
5 Trials studying Insulin Resistance
373 Patients Enrolled for Insulin Resistance

Media Library

Ertugliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04167761 — Phase < 1
Insulin Resistance Research Study Groups: Glipizide, Ertugliflozin
Insulin Resistance Clinical Trial 2023: Ertugliflozin Highlights & Side Effects. Trial Name: NCT04167761 — Phase < 1
Ertugliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167761 — Phase < 1
~4 spots leftby Dec 2025
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