Ertugliflozin 5 mg for Type 2 Diabetes

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Type 2 Diabetes+1 MoreErtugliflozin 5 mg - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial will see if a SGLTi2 inhibitor alters cardiac metabolism in people with HFpEF and DM2 compared to placebo.

Eligible Conditions
  • Type 2 Diabetes
  • Diastolic Heart Failure

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 12 weeks

12 weeks
Left ventricular mass index (gm/m2), as measured by cardiac MRI
Peak VO2, ml/kg/min, as measured by metabolic gas exchange
Serum ketone bodies (betahydroxybutyrate)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ertugliflozin 15 mg
10%Upper respiratory tract infection
10%Back pain
9%Hypoglycaemia
8%Urinary tract infection
7%Weight decreased
5%Arthralgia
5%Influenza
5%Headache
4%Cough
4%Viral upper respiratory tract infection
1%Peripheral ischaemia
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02033889) in the Ertugliflozin 15 mg ARM group. Side effects include: Upper respiratory tract infection with 10%, Back pain with 10%, Hypoglycaemia with 9%, Urinary tract infection with 8%, Weight decreased with 7%.

Trial Design

2 Treatment Groups

Ertugliflozin Treatment Arm
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

52 Total Participants · 2 Treatment Groups

Primary Treatment: Ertugliflozin 5 mg · Has Placebo Group · Phase 4

Ertugliflozin Treatment Arm
Drug
Experimental Group · 1 Intervention: Ertugliflozin 5 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ertugliflozin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
300 Previous Clinical Trials
337,608 Total Patients Enrolled
Trevor L Jenkins, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Eligibility Criteria

Age 18 - 75 · All Participants · 6 Total Inclusion Criteria

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