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SGLT2 Inhibitor

Dapagliflozin for Type 2 Diabetes (Hyper Trial)

Phase 4

Waitlist Available

Led By Ralph DeFronzo, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI = 20-45 kg/m2

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Hyper Trial Summary

This trial will test if dapagliflozin can reduce kidney size in patients with type 2 diabetes who have high levels of sugar in their urine.

Eligible Conditions

Type 2 Diabetes

Hyper Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Your body mass index (BMI) falls between 20 and 45 kg/m2.

Hyper Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GFR (Glomerular Filtration Rate) Change After Treatment

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471

20%

Cervicovaginal infection

13%

Urinary tract infections

100%

80%

60%

40%

20%

Study treatment Arm

Dapagliflozin

Placebo

Hyper Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Dapagliflozin/NormofiltrationExperimental Treatment1 Intervention

Subjects with eGFR below 124 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization will have add Dapagliflozin added to current metformin.

Group II: Dapagliflozin/HyperfiltrationExperimental Treatment1 Intervention

Subjects with eGFR above 125 ml/min per 1.73 m2 will be randomized to dapagliflozin, 5 mg/day. After 2 weeks (Visit 5), dapagliflozin will be increased to 10 mg/day, Subjects who are taking Metformin at time of randomization will have Dapagliflozin added to current metformin.

Group III: Metformin/HyperfiltrationActive Control2 Interventions

Subjects who Drug naïve we will give Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization will have Metformin- XR, 1000 mg/day added. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).

Group IV: Metformin/NormofiltrationActive Control2 Interventions

Subjects with eGFR below 124 ml/min per 1.73m2 drug naïve will receive Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).Subject who are on metformin at time of randomization we will add Glipizide 5 mg( to be increased to 10 mg at Visit 5), Subject who are on Glipizide at time of randomization we will add Metformin- XR, 1000 mg/day. After 2 weeks (Visit 5), metformin will be increased to 1000 mg bid (twice a day).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dapagliflozin

2014

Completed Phase 4

~64880

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,342 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,830 Total Patients Enrolled

Ralph DeFronzo, MDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio

11 Previous Clinical Trials

1,042 Total Patients Enrolled

Media Library

Dapagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02911792 — Phase 4

Type 2 Diabetes Research Study Groups: Metformin/Hyperfiltration, Dapagliflozin/Hyperfiltration, Dapagliflozin/Normofiltration, Metformin/Normofiltration

Type 2 Diabetes Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT02911792 — Phase 4

Dapagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02911792 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation include elderly participants aged 80 or beyond?

"Consistent with the study's criteria for enrollment, individuals must be between 30 and 70 years old to qualify."

Answered by AI

What diseases does Dapagliflozin typically ameliorate?

"Dapagliflozin is commonly prescribed to treat physical activity related conditions, as well as type 1 diabetes mellitus, medicinal formulas and diabetic ketoacidosis."

Answered by AI

Have prior experiments included Dapagliflozin in their research methodology?

"Since its inception in 2002 at George Washington University, 1244 clinical trials involving dapagliflozin have been completed. Nowadays, 227 active experiments are occurring across the globe--particularly concentrated around Spokane, WA."

Answered by AI

Which individuals meet the criteria to be accepted into this trial?

"This diabetes mellitus type 2 trial is looking for 23 participants between the ages of 30 and 70. Candidates must possess these criteria in order to qualify."

Answered by AI

Is this scientific experiment being conducted in many American medical centers?

"At this moment, 6 sites are taking part in the recruitment process for this clinical trial. These locations include Seattle, Chicago, and Orlando as well as 3 other cities. To reduce travel time if you enroll, it is vital to choose a clinic closest to your residence."

Answered by AI

Is enrollment now open for this research?

"Unfortuantely, no further participants are being accepted for this trial; the last update was made on October 10th 2022. Nevertheless, 1391 trials recruiting patients with diabetes mellitus type 2 and 227 studies seeking Dapagliflozin-related data are currently available."

Answered by AI

Is Dapagliflozin considered a safe pharmacological remedy?

"Considering the Phase 4 status of this medication, our team at Power has rated dapagliflozin a 3 on safety. This level indicates that it is already approved for use."

Answered by AI

What is the current scope of enrolment for this research?

"Unfortunately, no new patients are being accepted into this trial at the current moment. It was initially posted in December 2016 and has been most recently amended on October 2022. However, there is a wealth of other trials related to diabetes mellitus type 2 (1391) or dapagliflozin (227) that are actively enrolling participants."

Answered by AI