Type 1 DiabetesPhase 2NCT07594145
Precision T1D Platform - New Therapies for Cardio-Renal Complications
A Phase 2 study testing Finerenone and Sotagliflozin in people with Type 1 Diabetes and T1D Heart Failure, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health \& Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes, T1D Heart Failure, Cardio-renal Vascular Function and Failure
- What is being tested?
- Finerenone and Sotagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following:
- presence of circulating T1D-associated autoantibodies, or
- history of hospitalization for diabetic ketoacidosis, or
- documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose >100 mg/dL)
- Aged 18-75 years, inclusive
- T1D duration >10 years
Show all 11Show fewer
- HbA1c: 7-10%
- Meets one of the following, either
- UACR > 30 mg/dl with eGFR ≥ 60mL/min/1.73 m2 and receiving standard of care therapy for early DKD Stage 2, including renin angiotensin system blockade (RASB), unless contraindicated or not tolerated, or
- Early (Stage B HF) defined as NT-proBNP ≥125 pg/mL
- Willing and able to adhere to schedule of activities and protocol requirements, including written informed consent
Who cannot join
- Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease
- Use of any active platform treatment arms outside study assignment within 2 months prior to screening. See Appendix A for active treatment arms
- Current use of GLP-1 receptor agonists or other non-glucose lowering agent
- Use of aldosterone inhibitors within 2 months prior to screening
- Immunosuppressive medications within 3 months prior to screening
- Systolic BP>160 or diastolic BP >95 mmHg at screening
Show all 23Show fewer
- History of ≥3 severe hypoglycemic events requiring third-party assistance for correction within 3 months prior to screening
- Evidence of any episode of DKA or non-ketotic hyperosmolar state within 12 months prior to screening
- Serum potassium > 5.0 mmol/L at screening
- Absolute neutrophil count < 2.0 × 109 per L at screening
- Platelet count < 120 × 109 per L at screening
- Known active tuberculosis, hepatitis B or C at screening, or history of HIV
- Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or AST or ALT >2 times upper limit of normal, and/or total bilirubin >1.3 times upper limit of normal at screening
- History of severe acquired immune deficiency syndrome or severely immunocompromised status in the opinion of the study site investigator
- History of biopsy-proven non-diabetic CKD
- History of any other cause of HF (viral, congenital, valvular)
- History of heart or renal transplant or currently on chronic dialysis
- Cancer treatment, excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer, within one year prior to screening
- Illicit drug abuse within 6 months prior to screening in the opinion of the study site investigator
- Current heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week)
- Participation in another interventional clinical research study within 30 days prior to screening
- Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial
- Presence of a clinically significant medical history, physical examination, laboratory finding or other identified study site investigator concern that may interfere with any aspect of study conduct or interpretation of results
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Hailey Desmond, MS, (734) 764-6955, heturner@med.umich.edu
Lynn Ang, MD
Oregon Health & Science University
Portland, Oregon, 97239
Laura Nguyen, 971-509-4222, nguyelau@ohsu.edu
Aly Carlson, 971-610-3005
About this study
Official title: Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)
Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health \& Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.
Read the detailed description
This is a multicenter, open label pilot platform study to evaluate the impact of allocating patients with T1D and early signs of HF/DKD to targeted therapies based on their disease pathway activation signatures. The hypothesis is that stratifying T1D patients by molecularly-defined endophenotypes enables the use of targeted therapies that can more effectively prevent or slow cardio-renal complications.
There is no randomized allocation to treatment arms; rather, the eligible participant's clinical and biomarker data will be reviewed by the Molecular T1D Board which will adjudicate each participant to a treatment arm based on their based on their disease pathway activation signatures. Activation of different treatment arms may be initiated at different time points during the study.
The following sections describe the master protocol, outlining the requirements across all treatment arms, including the study-wide inclusion and exclusion criteria and study-wide procedures. Appendix A outlines any treatment arm/investigational agent specific information, including defining additional treatment-specific eligibility criteria and required study procedures.
The study schema can be found in Section 1.2 and the Schedule of Activities (SoA) in Section 1.3. Potential participants will undergo a two-part consent and screening process. The initial consent and screening visit will be limited to activities necessary for assessment by the Molecular T1D Board. Following review by the Molecular T1D Board, participants will be adjudicated to one treatment arm. At this time, participants will undergo the second consent and screening step, which will include information about specific requirements for their assigned investigational arm and, if in agreement, a complete eligibility assessment via a full screening visit. If the participant is deemed eligible, they will be notified and investigational product will be mailed to them directly. The screening visit results will also serve as the baseline results provided the first dose of study drug is taken within 14 (target) to 21 (limit) days of the screening visit. If more than 21 days, a retest of all laboratory measures will be performed.
Participants will receive open label treatment for 26 weeks, with planned study visits at weeks 2, 6, 12, 26, and 30. The total study duration of participation will be up to 36 weeks, inclusive of the screening period. Active study participation will conclude at Week 30 visit. Following completion of active study participation, participants will enter a passive follow-up period during which the study team may collect information on vital status, survival, hospitalizations, and other relevant clinical outcomes through review of medical records and other authorized data sources for up to 12 months after study participation ended. No additional protocol-required visits, procedures, or interventions will be conducted during the passive follow-up period. Participants will be enrolled in this study at Oregon Health \& Science University and the University of Michigan.
The currently planned number of study arms is three, with 15-19 participants enrolled in each arm. The study sponsors will have the option to increase the number of study arms and potential targeted therapies, which would be documented in the appendices and this master protocol.
- Conditions
- Type 1 Diabetes, T1D Heart Failure, Cardio-renal Vascular Function and Failure, Diabetic Chronic Kidney Disease
- Being tested
- Finerenone, Sotagliflozin
- Keywords
- Type 1 Diabetes, T1D, DKD, Heart Failure, Platform Trial
- Medical subject headings
- Diabetes Mellitus, Type 1, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Also called KERENDIA
Each treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.
SotagliflozinDrug
Also called INPEFA
Each treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Study participants with biomarker profiles showing a match for finerenone will be adjudicated to this treatment arm. The clinically recommended dose for finerenone based on manufacturer guidelines is 20 mg once daily (oral) if screening eGFR is ≥60 mL/min/1.73 m2. Receives: Drug: Finerenone |
| Sotagliflozin | Experimental | Study participants with biomarker profiles that match with sotagliflozin will be adjudicated to this treatment arm. The clinically recommended dose of sotagliflozin is 200 mg per the manufacturer guidelines. The dose of 200 mg has a lower DKA risk and similar kidney benefits to the higher doses. Receives: Drug: Sotagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of Renal Health [Safety and Tolerability]
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of renal health, defined as the percent change from baseline to week 26 in UACR.
Measured: 26 weeks
Markes of Cardio Health [Safety and Tolerability]
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of cardio health as defined by the percent change from baseline to week 26 in NT-proBNP.
Measured: 26 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary safety endpoints are defined as incidence of serious adverse events, adverse events and clinically significant abnormal laboratory tests.
Measured: 26 weeks
Secondary outcomes (3)
Immediate Outcomes of Renal Health (week 6)
The secondary endpoints are measures of immediate outcomes on markers of renal health as defined by changes from baseline to week 6 in UACR.
Measured: 20 weeks
Immediate Outcomes of Cardio Health (week 6)
The secondary endpoints are measures of immediate outcomes on markers of cardio health as defined by changes from baseline to week 6 in NT-proBNP.
Measured: 20 weeks
Immediate (week 6) and Early (week 26) Outcomes of Nephron Function Failure
The secondary endpoints are measures of immediate outcomes on markers of renal function failure as defined by changes from baseline to week 6 and from baseline to week 26 in eGFR.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A platform for personalized medicine where study participants will be assigned to specific treatment arms matched by their unique biomarker profiles.
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Breakthrough T1D
- Responsible party
- Principal investigator, Rodica Busui, Oregon Health and Science University
- Investigators
- Rodica Busui, MD, PhD, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594145
- Sponsor's protocol ID
- 30027
- Status last verified
- Aug 2026
- First submitted
- 11 May 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A limited dataset along with other study related materials (i.e., protocol, consent template, etc.) will be shared with other researchers/investigators at other institutions such as the University of Michigan via a data use agreement initiated by the primary site, Oregon Health \& Science University.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)
- ClinicalTrials.gov ID
- NCT07594145
- Acronym / sponsor ID
- 30027
- Conditions
- Type 1 Diabetes, T1D Heart Failure, Cardio-renal Vascular Function and Failure, Diabetic Chronic Kidney Disease
- Keywords
- Type 1 Diabetes, T1D, DKD, Heart Failure, Platform Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Breakthrough T1D
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health \& Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.
Detailed description
This is a multicenter, open label pilot platform study to evaluate the impact of allocating patients with T1D and early signs of HF/DKD to targeted therapies based on their disease pathway activation signatures. The hypothesis is that stratifying T1D patients by molecularly-defined endophenotypes enables the use of targeted therapies that can more effectively prevent or slow cardio-renal complications.
There is no randomized allocation to treatment arms; rather, the eligible participant's clinical and biomarker data will be reviewed by the Molecular T1D Board which will adjudicate each participant to a treatment arm based on their based on their disease pathway activation signatures. Activation of different treatment arms may be initiated at different time points during the study.
The following sections describe the master protocol, outlining the requirements across all treatment arms, including the study-wide inclusion and exclusion criteria and study-wide procedures. Appendix A outlines any treatment arm/investigational agent specific information, including defining additional treatment-specific eligibility criteria and required study procedures.
The study schema can be found in Section 1.2 and the Schedule of Activities (SoA) in Section 1.3. Potential participants will undergo a two-part consent and screening process. The initial consent and screening visit will be limited to activities necessary for assessment by the Molecular T1D Board. Following review by the Molecular T1D Board, participants will be adjudicated to one treatment arm. At this time, participants will undergo the second consent and screening step, which will include information about specific requirements for their assigned investigational arm and, if in agreement, a complete eligibility assessment via a full screening visit. If the participant is deemed eligible, they will be notified and investigational product will be mailed to them directly. The screening visit results will also serve as the baseline results provided the first dose of study drug is taken within 14 (target) to 21 (limit) days of the screening visit. If more than 21 days, a retest of all laboratory measures will be performed.
Participants will receive open label treatment for 26 weeks, with planned study visits at weeks 2, 6, 12, 26, and 30. The total study duration of participation will be up to 36 weeks, inclusive of the screening period. Active study participation will conclude at Week 30 visit. Following completion of active study participation, participants will enter a passive follow-up period during which the study team may collect information on vital status, survival, hospitalizations, and other relevant clinical outcomes through review of medical records and other authorized data sources for up to 12 months after study participation ended. No additional protocol-required visits, procedures, or interventions will be conducted during the passive follow-up period. Participants will be enrolled in this study at Oregon Health \& Science University and the University of Michigan.
The currently planned number of study arms is three, with 15-19 participants enrolled in each arm. The study sponsors will have the option to increase the number of study arms and potential targeted therapies, which would be documented in the appendices and this master protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A platform for personalized medicine where study participants will be assigned to specific treatment arms matched by their unique biomarker profiles.
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: FinerenoneStudy participants with biomarker profiles showing a match for finerenone will be adjudicated to this treatment arm. The clinically recommended dose for finerenone based on manufacturer guidelines is 20 mg once daily (oral) if screening eGFR is ≥60 mL/min/1.73 m2. |
| Sotagliflozin | Experimental | Drug: SotagliflozinStudy participants with biomarker profiles that match with sotagliflozin will be adjudicated to this treatment arm. The clinically recommended dose of sotagliflozin is 200 mg per the manufacturer guidelines. The dose of 200 mg has a lower DKA risk and similar kidney benefits to the higher doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following:
- Aged 18-75 years, inclusive
- T1D duration >10 years
- HbA1c: 7-10%
- Meets one of the following, either
Key exclusion criteria (23 listed)
- Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease
- Use of any active platform treatment arms outside study assignment within 2 months prior to screening. See Appendix A for active treatment arms
- Current use of GLP-1 receptor agonists or other non-glucose lowering agent
- Use of aldosterone inhibitors within 2 months prior to screening
- Immunosuppressive medications within 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneAlso: KERENDIAEach treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion. | Drug | Finerenone |
| SotagliflozinAlso: INPEFAEach treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion. | Drug | Sotagliflozin |
Primary outcome
Markers of Renal Health [Safety and Tolerability]
Time frame: 26 weeks
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of renal health, defined as the percent change from baseline to week 26 in UACR.
Markes of Cardio Health [Safety and Tolerability]
Time frame: 26 weeks
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of cardio health as defined by the percent change from baseline to week 26 in NT-proBNP.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 26 weeks
The primary safety endpoints are defined as incidence of serious adverse events, adverse events and clinically significant abnormal laboratory tests.
3 secondary outcomes
Immediate Outcomes of Renal Health (week 6)
Time frame: 20 weeks
Immediate Outcomes of Cardio Health (week 6)
Time frame: 20 weeks
Immediate (week 6) and Early (week 26) Outcomes of Nephron Function Failure
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. A limited dataset along with other study related materials (i.e., protocol, consent template, etc.) will be shared with other researchers/investigators at other institutions such as the University of Michigan via a data use agreement initiated by the primary site, Oregon Health \& Science University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodica Busui, MD, PhD study chair
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finerenone and Sotagliflozin in people with Type 1 Diabetes and T1D Heart Failure, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Nguyen ((971) 509-4222, nguyelau@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of Renal Health [Safety and Tolerability] (time frame: 26 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.