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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02911792




Registration number
NCT02911792
Ethics application status
Date submitted
16/09/2016
Date registered
22/09/2016
Date last updated
30/11/2023

Titles & IDs
Public title
Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration
Scientific title
Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration
Secondary ID [1] 0 0
HSC20160262H
Universal Trial Number (UTN)
Trial acronym
Hyper
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Dapagliflozin/Hyperfiltration - 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.

Active comparator: Metformin/Hyperfiltration - 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).

Experimental: Dapagliflozin/Normofiltration - 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.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Newly diagnosed, drug naïve, hyperfiltering and normofiltration patients with type 2 diabetes mellitus (T2DM)
* Hyperfiltration is defined by GFR >135 ml/min•1.73m2
* Normofiltration by a GFR = 90-134 ml/min•1.73m2
* BMI = 20-45 kg/m2
* HbA1c = 7.5% to 12%
* Willingness to participate in the 16 week study protocol
* Hematocrit >34% --BP < 145/90 mmHg
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* > 300 mg/day albumin excretion
* Ingestion of medications known to interfere with the renin-angiotensin system or renal function, including diuretic therapy
* Hospitalization for unstable angina, history of recent macrovascular (MI/stroke/TIA/ACS) disease, coronary artery revascularization (within 2 months prior to enrollment)
* Proliferative diabetic retinopathy
* History of cancer or major organ system disease
* New York Heart class II-IV heart failure Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3x ULN or total bilirubin > 2.0 mg/dL (34.2 µmo/L)
* Treatment with steroids, beta blockers, alpha blockers, antiobesity drugs
* Pregnant or nursing mothers
* Premenopausal females who are not practicing acceptable contraceptive methods Participation in another trial with an investigational drug within 30 days Alcohol or drug abuse within the preceding 6 months
* Any condition, psychiatric or medical, which in the opinion of the investigator would interfere with the successful completion of the study
* Orthostatic hypotension (> 15/10 mmHg decrease upon standing for 3 minutes)
* Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen, Hepatitis C virus antibody and HIV
* Volume depleted patients
* Estimated glomerular filtration rate <60 mL/min•1.73m2. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/07/2023
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Texas Health Science Center at San Antonio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated group will serve as controls for improved glycemic control, since the investigators have shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM patients.
Trial website
https://clinicaltrials.gov/study/NCT02911792
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Ralph DeFronzo, MD
Address 0 0
The University of Texas Health Science Center at San Antonio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02911792