dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

NCT ID: NCT06072326

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

Brief Summary

The aim of this study is to test the hypothesis that dapagliflozin (SGLT2 inhibitor) and SC0062 (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.

Detailed Description

A phase 2, multicenter, randomized, open-label, cross-over trial will be conducted in male or female individuals (N=36) diagnosed with type 1 diabetes at least 6 months prior to informed consent aged between 18 and 65 years, Body Mass Index (BMI) ≥ 21 kg/m2, urinary albumin: creatinine ratio ≥ 50 mg/g and < 3000 mg/g, eGFR > 30 and <90 mL/min/1.73 m2 and HbA1c > 6.5 and <10.5%. Patients have to be on stable RAAS inhibition for at least 4 weeks prior to screening.

The study will consist of a screening visit, a 4-week run-in phase. After the run-in phase, the participant will be randomized to treatment of SC0062, dapagliflozin, or their combination in random order. The duration of each treatment period is 4 weeks with study visits scheduled at 2 and 4 weeks in each treatment period. At the end of each treatment period patients proceed to a 4 weeks wash-out phase to study off drug effects. The total duration of the study for each participant after randomization is thus 24 weeks

Interventions SC0062 10mg twice daily (20mg/day); dapagliflozin 5mg once daily; combination of SC0062 10mg twice daily and dapagliflozin 5mg once daily.

Conditions

Type 1 Diabetes Mellitus With Diabetic Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment order 1

Subjects will start with 4 weeks of SC0062 in treatment period 1. In period 2 subjects will receive dapagliflozin. In period 3 subjects will receive a combination of SC0062 and dapagliflozin. Between treatment periods there is a 4-week wash-out.

Group Type: EXPERIMENTAL

Dapagliflozin (Forxiga®)

Intervention Type: DRUG

5 mg/day as a tablet

SC0062 strength 10mg

Intervention Type: DRUG

20 mg/day, twice daily, capsule

SC0062 and dapagliflozin

Intervention Type: DRUG

20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Treatment order 2

Subjects will start with 4 weeks of SC0062 in treatment period 1. In period 2 subjects will receive a combination of SC0062 and dapagliflozin. In period 3 subjects will receive dapagliflozin. Between treatment periods there is a 4-week wash-out.

Group Type: EXPERIMENTAL

Dapagliflozin (Forxiga®)

Intervention Type: DRUG

5 mg/day as a tablet

SC0062 strength 10mg

Intervention Type: DRUG

20 mg/day, twice daily, capsule

SC0062 and dapagliflozin

Intervention Type: DRUG

20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Treatment order 3

Subjects will start with 4 weeks of dapagliflozin in treatment period 1. In period 2 subjects will receive a combination of SC0062 and dapagliflozin. In period 3 subjects will receive SC0062. Between treatment periods there is a 4-week wash-out.

Group Type: EXPERIMENTAL

Dapagliflozin (Forxiga®)

Intervention Type: DRUG

5 mg/day as a tablet

SC0062 strength 10mg

Intervention Type: DRUG

20 mg/day, twice daily, capsule

SC0062 and dapagliflozin

Intervention Type: DRUG

20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Treatment order 4

Subjects will start with 4 weeks of dapagliflozin in treatment period 1. In period 2 subjects will receive SC0062. In period 3 subjects will receive a combination of SC0062 and dapagliflozin. Between treatment periods there is a 4-week wash-out.

Group Type: EXPERIMENTAL

Dapagliflozin (Forxiga®)

Intervention Type: DRUG

5 mg/day as a tablet

SC0062 strength 10mg

Intervention Type: DRUG

20 mg/day, twice daily, capsule

SC0062 and dapagliflozin

Intervention Type: DRUG

20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Treatment order 5

Subjects will start with 4 weeks of a combination of SC0062 and dapagliflozin in period 1. In period 2 subjects will receive SC0062. In period 3 subjects will receive dapagliflozin. Between treatment periods there is a 4-week wash-out.

Group Type: EXPERIMENTAL

Dapagliflozin (Forxiga®)

Intervention Type: DRUG

5 mg/day as a tablet

SC0062 strength 10mg

Intervention Type: DRUG

20 mg/day, twice daily, capsule

SC0062 and dapagliflozin

Intervention Type: DRUG

20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Treatment order 6

Subjects will start with 4 weeks of a combination of SC0062 and dapagliflozin in period 1. In period 2 subjects will receive dapagliflozin. In period 3 subjects will receive SC0062. Between treatment periods there is a 4-week wash-out.

Group Type: EXPERIMENTAL

Dapagliflozin (Forxiga®)

Intervention Type: DRUG

5 mg/day as a tablet

SC0062 strength 10mg

Intervention Type: DRUG

20 mg/day, twice daily, capsule

SC0062 and dapagliflozin

Intervention Type: DRUG

20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Interventions

Dapagliflozin (Forxiga®)

5 mg/day as a tablet

Intervention Type: DRUG

SC0062 strength 10mg

20 mg/day, twice daily, capsule

Intervention Type: DRUG

SC0062 and dapagliflozin

20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing and able to sign informed consent
• Male or female individuals diagnosed with type 1 diabetes at least 6 months prior to informed consent
• WOCBP must have a negative pregnancy test at screening and must not be lactating.
• Male individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, or be able to provide proof of vasectomy.
• Female individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, provide proof of hysterectomy or sterilization, or be deemed menopausal based on a FSH-test.
• Age ≥18 and <65years, at the time of signing consent.
• Body Mass Index ≥ 21 kg/m2
• Urinary albumin:creatinine ratio ≥ 50 mg/g and <3000 mg/g
• eGFR ≥30 and <90 ml/min/1.73m2
• Stable RAAS inhibition medication for at least 4 weeks prior to screening
• HbA1c ≥6.5 and <10.5%.
• Based on the Investigator's judgment participant must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed before randomization):

• patient-led management and adjustment of insulin therapy
• reliable approach to insulin dose adjustment for meals, such as carbohydrate counting
• reliable and regular home-based blood glucose monitoring
• established "sick day" management regimen

Exclusion Criteria

• Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA).
• Treatment with an anti-hyperglycaemic agent (e.g., metformin, alpha-glucosidase inhibitors, pramlintide, glucagon-like peptide receptor agonist, etc.) within 3 months.
• Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months.
• Hypoglycaemia unawareness based on Investigator judgement or frequent episodes of unexplained hypoglycaemia (2 or more unexplained episodes within 3 months).
• Occurrence of diabetic ketoacidosis within 6 months prior to study enrolment.
• Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 6 months.
• Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g., immunocompromised patients, patients who might be at higher risk of developing urinary, genital or mycotic infections, patients with chronic viral infections, etc.).
• Treatment with an SGLT2i within 30 days of Visit 1.
• NT-proBNP > 600 pg/mL
• Hemoglobin < 90 g/L
• Diagnosis of severe edema (per investigator judgment) within 3 months of screening
• Diagnosis of heart failure (NYHC stage III or IV).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Biocity Biopharmaceutics Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiddo J Lambers Heerspink, PhD, PharmD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

Steno Diabetes Center Aarhus

Aarhus, , Denmark

Steno Diabetes Center Copenhagen

Copenhagen, , Denmark

Regionshospitalet Gødstrup

Herning, , Denmark

University of Helsinki

Helsinki, Uusimaa, Finland

Turku University Hospital

Turku, , Finland

Amsterdam University Academic Center

Amsterdam, North Holland, Netherlands

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Denmark; Finland; Netherlands

Central Contacts

Hiddo J Lambers Heerspink, Phd, PharmD

Role: CONTACT

h.j.lambers.heerspink@umcg.nl

+31-50-3617859

Facility Contacts

Søren T Knudsen

Role: primary

Tine W Hansen

Role: primary

Jesper N Bech

Role: primary

Daniel Gordin

Role: primary

Tapio A. Hellman

Role: primary

Daniel van Raalte

Role: primary

Helen Lutgers

Role: primary

Other Identifiers

2023-504404-28-00

Identifier Type: CTIS

Identifier Source: secondary_id

17042

Identifier Type: -

Identifier Source: org_study_id