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SGLT2 Inhibitor
Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration (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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to treat newly diagnosed Type 2 Diabetes patients with dapagliflozin or metformin. Dapagliflozin helps reduce kidney pressure and size by removing sugar through urine, while metformin controls blood sugar levels. The goal is to see if dapagliflozin can better protect the kidneys compared to metformin. Dapagliflozin was initially developed for type 2 diabetes and has shown benefits in reducing heart and kidney problems.
Eligible Conditions
- Type 2 Diabetes
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GFR (Glomerular Filtration Rate) Change After Treatment
Side effects data
From 2018 Phase 4 trial • 30 Patients • NCT0300647120%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~64440
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,847 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,411 Previous Clinical Trials
289,123,521 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
11 Previous Clinical Trials
958 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) falls between 20 and 45 kg/m2.You have had cancer or a serious disease affecting your major organs in the past.You have moderate to severe heart failure.You are currently taking steroids, beta blockers, alpha blockers, or antiobesity drugs.You have been using alcohol or drugs excessively in the past 6 months.You are willing to participate in the study for 16 weeks.You are taking medications that can affect your kidneys or the renin-angiotensin system, including diuretics.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin/Hyperfiltration
- Group 2: Dapagliflozin/Hyperfiltration
- Group 3: Dapagliflozin/Normofiltration
- Group 4: Metformin/Normofiltration
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.