NCT05345327

Brief Summary

The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
994

participants targeted

Target at P75+ for phase_3 type-2-diabetes

Timeline
2mo left

Started Jan 2023

Longer than P75 for phase_3 type-2-diabetes

Geographic Reach
2 countries

8 active sites

Status
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 Progress96%
Jan 2023Jun 2026

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

3.5 years

First QC Date

April 19, 2022

Last Update Submit

December 17, 2024

Conditions

Type 2 Diabetes

Keywords

DiabetesRenal declineMetforminSodium Glucose Co-Transporter 2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Rate of decline in eGFR

    Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year

    24 months

Secondary Outcomes (8)

  • Urine albumin creatinine ratio

    24 months

  • Serum creatinine

    24 months

  • HbA1C

    24 months

  • Fasting blood glucose

    24 months

  • Systolic and diastolic blood pressure

    24 months

  • +3 more secondary outcomes

Study Arms (2)

Dapagliflozin 10mg

EXPERIMENTAL

1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years

Drug: Dapagliflozin

Metformin XR 2000mg

ACTIVE COMPARATOR

2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years

Drug: Metformin

Interventions

DapagliflozinDRUG

SGLT2 inhibitor

Dapagliflozin 10mg
MetforminDRUG

Metformin

Metformin XR 2000mg

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of T2D;
  • Aged ≥18 years;
  • Body mass index \> 18.5 kg/m2;
  • Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;
  • eGFR ≥45 ml/min/1,73m2; and
  • Signed informed consent.

You may not qualify if:

  • Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or
  • There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor; or
  • They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) or clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); or
  • Pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

The George Institute for Global Health

Sydney, New South Wales, 2042, Australia

RECRUITING

The George Institute for Global Health

Brisbane, Queensland, 4000, Australia

RECRUITING

Monash University

Melbourne, Victoria, 3004, Australia

RECRUITING

National Hospital - Galle

Galle, Southern Province, 80000, Sri Lanka

NOT YET RECRUITING

National Hospital of Sri Lanka 1

Colombo, 00700, Sri Lanka

RECRUITING

National Hospital of Sri Lanka 2

Colombo, 00700, Sri Lanka

NOT YET RECRUITING

Jaffna Teaching Hospital

Jaffna, 40000, Sri Lanka

RECRUITING

Kandy National Hospital

Kandy, 20000, Sri Lanka

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

dapagliflozinMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Bruce Neal

    The George Institute for Global Health (Sydney, Australia)

    STUDY CHAIR

  • Clare Arnott

    The George Institute for Global Health (Sydney, Australia)

    STUDY CHAIR

Central Study Contacts

Emma Zhang

CONTACT

+61 2 8052 4337ezhang1@georgeinstitute.org.au

Sarah Stanton

CONTACT

sstanton@georgeinstitute.org.au

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

January 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Locations

SR(5)AU(3)