Trial · Observational

CompletedPhase not statedResults postedRegistry data

Early Add-On Combination of GLP-1 Receptor Agonist and SGLT2 Inhibitor in People With Cardiovascular-Kidney-Metabolic Stage 2-3

Short name GLP1-SGLT2-CKM

NCTNCT07465926Other idCS1-25149Other idNSTC 113-2314-B-040-026-MY2Other idNSTC 114-2622-B-040-001Other idCSH-2025-C-012

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Glucagon, does not test it. It appears in the description.

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 451,036 participants (actual)
Sponsor: Chung Shan Medical University · Other
Design: Not stated
Countries: Not stated
Start: 1 Jan 2017
Primary completion: 31 Jan 2026
Completion: 31 Jan 2026
First posted: 12 Mar 2026
Last update posted: 22 Jun 2026
Conditions: Cardiovascular-kidney-metabolic Syndrome · Cardiovascular Disease Risk Factor · Kidney Disease · Type 2 Diabetes · Obesity & Overweight

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182020202220242026

Ph –
GLP1-SGLT2-CKM
NCT07465926
1 Jan 2017 to 31 Jan 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare early treatment intensification strategies in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiate a GLP-1 receptor agonist or an SGLT2 inhibitor. The study compares patients who, within 90 days of starting background therapy, add the alternate agent, add a DPP-4 inhibitor or sulfonylurea, or do not receive early add-on therapy. The primary outcome is all-cause mortality over 36 months, with secondary cardiorenal outcomes also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.

Interventions

GLP-1 receptor agonistDrug
SGLT2 inhibitorDrug

Arms2

Other
GLP-1 RA Base Therapy
Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated a GLP-1 receptor agonist as base therapy after a 6-month washout from GLP-1 RA, SGLT2i, DPP-4i, and sulfonylureas. Within this cohort, participants were classified by the first add-on treatment within 90 days into three mutually exclusive strategies: SGLT2i add-on, DPP-4i or sulfonylurea add-on, or no early add-on.
Other
SGLT2i Base Therapy
Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated an SGLT2 inhibitor as base therapy after a 6-month washout from GLP-1 RA, SGLT2i, DPP-4i, and sulfonylureas. Within this cohort, participants were classified by the first add-on treatment within 90 days into three mutually exclusive strategies: GLP-1 RA add-on, DPP-4i or sulfonylurea add-on, or no early add-on.

Primary outcomes4

Outcomes the sponsor listed as primary.

All-cause Mortality (Comparison 1)
Time frame · From index through 36 months
Registry description
All-cause mortality within 36 months in the propensity score-matched cohort for Comparison 1, comparing GLP-1 RA with SGLT2i add-on versus GLP-1 RA with DPP-4 inhibitor or sulfonylurea add-on in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
All-cause Mortality (Comparison 2)
Time frame · From index through 36 months
Registry description
All-cause mortality within 36 months in the propensity score-matched cohort for Comparison 2, comparing GLP-1 RA with SGLT2i add-on versus GLP-1 RA without early add-on treatment in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
All-cause Mortality (Comparison 3)
Time frame · From index through 36 months
Registry description
All-cause mortality within 36 months in the propensity score-matched cohort for Comparison 3, comparing SGLT2i with GLP-1 RA add-on versus SGLT2i with DPP-4 inhibitor or sulfonylurea add-on in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
All-cause Mortality (Comparison 4)
Time frame · From index through 36 months
Registry description
All-cause mortality within 36 months in the propensity score-matched cohort for Comparison 4, comparing SGLT2i with GLP-1 RA add-on versus SGLT2i without early add-on treatment in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.

Secondary outcomes(8)

Major Adverse Cardiovascular Events (MACE) (Comparison 1)
Time frame · From index through 36 months
Registry description
Major adverse cardiovascular events within 36 months in the propensity score-matched cohort for Comparison 1, comparing GLP-1 RA with SGLT2i add-on versus GLP-1 RA with DPP-4 inhibitor or sulfonylurea add-on in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
Major Adverse Cardiovascular Events (MACE) (Comparison 2)
Time frame · From index through 36 months
Registry description
Major adverse cardiovascular events within 36 months in the propensity score-matched cohort for Comparison 2, comparing GLP-1 RA with SGLT2i add-on versus GLP-1 RA without early add-on treatment in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
Major Adverse Cardiovascular Events (MACE) (Comparison 3)
Time frame · From index through 36 months
Registry description
Major adverse cardiovascular events within 36 months in the propensity score-matched cohort for Comparison 3, comparing SGLT2i with GLP-1 RA add-on versus SGLT2i with DPP-4 inhibitor or sulfonylurea add-on in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
Major Adverse Cardiovascular Events (MACE) (Comparison 4)
Time frame · From index through 36 months
Registry description
Major adverse cardiovascular events within 36 months in the propensity score-matched cohort for Comparison 4, comparing SGLT2i with GLP-1 RA add-on versus SGLT2i without early add-on treatment in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
Major Adverse Kidney Events (MAKE) (Comparison 1)
Time frame · From index through 36 months
Registry description
Major adverse kidney events within 36 months in the propensity score-matched cohort for Comparison 1, comparing GLP-1 RA with SGLT2i add-on versus GLP-1 RA with DPP-4 inhibitor or sulfonylurea add-on in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
Major Adverse Kidney Events (MAKE) (Comparison 2)
Time frame · From index through 36 months
Registry description
Major adverse kidney events within 36 months in the propensity score-matched cohort for Comparison 2, comparing GLP-1 RA with SGLT2i add-on versus GLP-1 RA without early add-on treatment in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
Major Adverse Kidney Events (MAKE) (Comparison 3)
Time frame · From index through 36 months
Registry description
Major adverse kidney events within 36 months in the propensity score-matched cohort for Comparison 3, comparing SGLT2i with GLP-1 RA add-on versus SGLT2i with DPP-4 inhibitor or sulfonylurea add-on in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.
Major Adverse Kidney Events (MAKE) (Comparison 4)
Time frame · From index through 36 months
Registry description
Major adverse kidney events within 36 months in the propensity score-matched cohort for Comparison 4, comparing SGLT2i with GLP-1 RA add-on versus SGLT2i without early add-on treatment in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· From index through 36 months

All-cause Mortality (Comparison 1)

Group	Value (participants with event)
GLP-1 RA With SGLT2i Add-On (Comparison 1)	291
GLP-1 RA With DPP-4i/SU Add-On (Comparison 1)	444

Primary outcomeNumber· From index through 36 months

All-cause Mortality (Comparison 2)

Group	Value (participants with event)
GLP-1 RA With SGLT2i Add-On (Comparison 2)	674
GLP-1 RA Only (No Early Add-On) (Comparison 2)	877

Primary outcomeNumber· From index through 36 months

All-cause Mortality (Comparison 3)

Group	Value (participants with event)
SGLT2i With GLP-1 RA Add-On (Comparison 3)	352
SGLT2i With DPP-4i/SU Add-On (Comparison 3)	562

Primary outcomeNumber· From index through 36 months

All-cause Mortality (Comparison 4)

Group	Value (participants with event)
SGLT2i With GLP-1 RA Add-On (Comparison 4)	593
SGLT2i Only (No Early Add-On) (Comparison 4)	770

Secondary and other outcome results(4)

Secondary outcomeNumber· From index through 36 months

Major Adverse Cardiovascular Events (MACE) (Comparison 1)

Group	Value (participants with event)
GLP-1 RA With SGLT2i Add-On (Comparison 1)	490
GLP-1 RA With DPP-4i/SU Add-On (Comparison 1)	553

Secondary outcomeNumber· From index through 36 months

Major Adverse Cardiovascular Events (MACE) (Comparison 2)

Group	Value (participants with event)
GLP-1 RA With SGLT2i Add-On (Comparison 2)	1137
GLP-1 RA Only (No Early Add-On) (Comparison 2)	1193

Secondary outcomeNumber· From index through 36 months

Major Adverse Cardiovascular Events (MACE) (Comparison 3)

Group	Value (participants with event)
SGLT2i With GLP-1 RA Add-On (Comparison 3)	567
SGLT2i With DPP-4i/SU Add-On (Comparison 3)	722

Secondary outcomeNumber· From index through 36 months

Major Adverse Cardiovascular Events (MACE) (Comparison 4)

Group	Value (participants with event)
SGLT2i With GLP-1 RA Add-On (Comparison 4)	994
SGLT2i Only (No Early Add-On) (Comparison 4)	1106

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GLP-1 RA With SGLT2i Add-On (Comparison 1)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated a GLP-1 receptor agonist as base therapy and were classified as having SGLT2 inhibitor add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 1.	291 / 16,864	754 / 16,796	0 / 0
GLP-1 RA With DPP-4i/SU Add-On (Comparison 1)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated a GLP-1 receptor agonist as base therapy and were classified as having DPP-4 inhibitor or sulfonylurea add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 1.	444 / 16,827	983 / 16,734	0 / 0
GLP-1 RA With SGLT2i Add-On (Comparison 2)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated a GLP-1 receptor agonist as base therapy and were classified as having SGLT2 inhibitor add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 2.	674 / 39,552	1862 / 39,392	0 / 0
GLP-1 RA Only (No Early Add-On) (Comparison 2)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated a GLP-1 receptor agonist as base therapy and did not receive early add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 2.	877 / 39,518	2073 / 39,243	0 / 0
SGLT2i With GLP-1 RA Add-On (Comparison 3)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated an SGLT2 inhibitor as base therapy and were classified as having GLP-1 receptor agonist add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 3.	352 / 18,850	854 / 18,771	0 / 0
SGLT2i With DPP-4i/SU Add-On (Comparison 3)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated an SGLT2 inhibitor as base therapy and were classified as having DPP-4 inhibitor or sulfonylurea add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 3.	562 / 18,941	1223 / 18,868	0 / 0
SGLT2i With GLP-1 RA Add-On (Comparison 4)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated an SGLT2 inhibitor as base therapy and were classified as having GLP-1 receptor agonist add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 4.	593 / 34,963	1495 / 34,819	0 / 0
SGLT2i Only (No Early Add-On) (Comparison 4)Adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiated an SGLT2 inhibitor as base therapy and did not receive early add-on treatment within 90 days during the initial treatment assessment period. This group represents the propensity score-matched cohort for Comparison 4.	770 / 34,987	1727 / 34,827	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2024

7 results

Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.

Perkovic et al. 2024The New England journal of medicinecited by 1,523

PMID 38785209DOI 10.1056/nejmoa2403347PUB-38785209

Full text at the publisher7 results

Publisher page See results (7)

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results

Source link See results (8)

More studies

4 studies on this page

Indexing hint: Review · 2025

Corrected

GLP-1-based therapies for diabetes, obesity and beyond.

Drucker et al. 2025Nature reviews. Drug discoverycited by 133

PMID 40281304DOI 10.1038/s41573-025-01183-8PUB-40281304

Full text at the publisher

Publisher page Read the notice

Indexing hint: Review · 2024

GLP-1 Receptor Agonists and SGLT2 Inhibitors in Type 2 Diabetes: Pleiotropic Cardiometabolic Effects and Add-on Value of a Combined Therapy.

Scheen et al. 2024Drugscited by 32

PMID 39342059DOI 10.1007/s40265-024-02090-9PUB-39342059

Full text at the publisher

Publisher page

PubMed tag: none · 2023

Effects of once-weekly semaglutide 2.4 mg on C-reactive protein in adults with overweight or obesity (STEP 1, 2, and 3): Exploratory analyses of three randomised, double-blind, placebo-controlled, phase 3 trials.

Verma et al. 2023EClinicalMedicinecited by 75

PMID 36467859PMC9713290DOI 10.1016/j.eclinm.2022.101737PUB-36467859

CC BY

Download PDF

Indexing hint: Meta-analysis (pooled) · 2019

Corrected

Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials.

Kristensen et al. 2019The lancet. Diabetes & endocrinologycited by 1,238

PMID 31422062DOI 10.1016/s2213-8587(19)30249-9PUB-31422062

Rights unknown

Source link Read the notice

Eligibility

Who could join, as posted.

Sex: All
Age: from 20 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Adults aged 20 years or older. * Obesity, defined by body mass index (BMI) 27 kg/m2 or greater. * Type 2 diabetes mellitus, defined using electronic health record data, including diagnosis codes and/or hemoglobin A1c 6.5% or greater. * Met cardiovascular-kidney-metabolic (CKM) stage 2-3 criteria at baseline. * Initiated a GLP-1 receptor agonist or an SGLT2 inhibitor as background therapy. * Had treatment strategy classification based on early add-on initiation within 90 days after background therapy initiation, or no early add-on with index at the 90-day landmark. Exclusion Criteria: * Prior use of GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas within 6 months before cohort entry. * Major cardiovascular disease or revascularization within 12 months before cohort entry. * Advanced kidney disease within 12 months before cohort entry, including end-stage kidney disease, dialysis, or estimated glomerular filtration rate less than 15 mL/min/1.73 m2. * Major cardiovascular or renal events within 6 months before index. * Any history of non-type 2 diabetes, HIV infection, bariatric surgery, or solid-organ transplantation. * Missing critical baseline covariates.

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