NCT06072326

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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
32mo left

Started Jan 2026

Typical duration for phase_2

Geographic Reach
3 countries

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

October 2, 2023

Last Update Submit

October 1, 2025

Conditions

Type 1 Diabetes Mellitus With Diabetic Nephropathy

Keywords

Diabetic kidney diseasesodium glucose co-transporter 2 inhibitorsendothelin receptor antagonistsType 1 Diabetescombination therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Urine Albumin-Creatinine Ratio (UACR)

    Primary: change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.

    4 weeks

Secondary Outcomes (7)

  • Change from baseline in mGFR

    4 weeks

  • Change in biomarkers of fluid retention

    4 weeks

  • Change in biomarkers of fluid retention

    4 weeks

  • Change in biomarkers of fluid retention

    4 weeks

  • Change in biomarkers of fluid retention

    4 weeks

  • +2 more secondary outcomes

Study Arms (6)

Treatment order 1

EXPERIMENTAL

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.

Drug: Dapagliflozin (Forxiga®)Drug: SC0062 strength 10mgDrug: SC0062 and dapagliflozin

Treatment order 2

EXPERIMENTAL

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.

Drug: Dapagliflozin (Forxiga®)Drug: SC0062 strength 10mgDrug: SC0062 and dapagliflozin

Treatment order 3

EXPERIMENTAL

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.

Drug: Dapagliflozin (Forxiga®)Drug: SC0062 strength 10mgDrug: SC0062 and dapagliflozin

Treatment order 4

EXPERIMENTAL

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.

Drug: Dapagliflozin (Forxiga®)Drug: SC0062 strength 10mgDrug: SC0062 and dapagliflozin

Treatment order 5

EXPERIMENTAL

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.

Drug: Dapagliflozin (Forxiga®)Drug: SC0062 strength 10mgDrug: SC0062 and dapagliflozin

Treatment order 6

EXPERIMENTAL

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.

Drug: Dapagliflozin (Forxiga®)Drug: SC0062 strength 10mgDrug: SC0062 and dapagliflozin

Interventions

Dapagliflozin (Forxiga®)DRUG

5 mg/day as a tablet

Treatment order 1Treatment order 2Treatment order 3Treatment order 4Treatment order 5Treatment order 6
SC0062 strength 10mgDRUG

20 mg/day, twice daily, capsule

Treatment order 1Treatment order 2Treatment order 3Treatment order 4Treatment order 5Treatment order 6
SC0062 and dapagliflozinDRUG

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 1Treatment order 2Treatment order 3Treatment order 4Treatment order 5Treatment order 6

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

Location

Steno Diabetes Center Copenhagen

Copenhagen, 2730 Herlev, Denmark

Location

Regionshospitalet Gødstrup

Herning, 7400, Denmark

Location

University of Helsinki

Helsinki, Uusimaa, 00029 HUS, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

Amsterdam University Academic Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 1

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Hiddo J Lambers Heerspink, PhD, PharmD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiddo J Lambers Heerspink, Phd, PharmD

CONTACT

+31-50-3617859h.j.lambers.heerspink@umcg.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Multicenter, open-label randomized cross-over trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)FI(2)DK(3)