Current partner codePEPTIDESDE
NCT05220917·Not applicable·OBSERVATIONAL

Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study

Status

Active, not recruiting

Phase

Not applicable

Enrollment

781,430

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

To perform an observational analysis to emulate a target trial (i.e., a hypothetical pragmatic trial that would have answered the causal question of interest) comparing the effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons in patients with type 2 diabetes (T2D).

Full detailed description

Aim 1: (1a.) To evaluate the effectiveness of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons with respect to cardiovascular (CV) events, mortality, renal events, and other patient-centered outcomes (e.g., time spent at home), in patients with T2D and moderate baseline CV risk (event rate ≤3%/year). (1b.) To examine heterogeneity in treatment effects by age, race/ethnicity, gender, levels of CV risk, including high (≥4%/year) and low risk (\<2%/year), chronic kidney disease (CKD), frailty, and multimorbidity. Aim 2: (2a.) To monitor and quantify the association of the initiation of SGLT2i, GLP-1RA, DPP-4i, or SU, at the class and individual agent level, with previously reported drug-related harms (e.g., diabetic ketoacidosis (DKA), fractures, amputations, pancreatitis, severe hypoglycemia). (2b.) To scan study data sources for signals of potential serious unanticipated drug-related adverse events, using a data-mining approach (tree-based scan statistics). (2c.) By using data generated in Aims 2a and 2b, to build treatment-specific outcome prediction models to identify individual patients' likelihood of drug-related harms, based on specific combinations of patient features.

Interventions

Treatment arms and agents.

DRUG

SGLT2 inhibitor

Any SGLT2i dispensing claim

DRUG

DPP-4 inhibitor

Any DPP-4 inhibitor claim

DRUG

GLP-1RA

Any SGLT2i dispensing claim

DRUG

2nd generation SU

Any 2nd generation SU claim

Timeline

From registration to results.

  1. First posted

    Feb 2, 2022

  2. Study start

    Aug 1, 2021

  3. Primary completion

    May 31, 2026

  4. Study completion

    Sep 30, 2027

  5. Results posted

    Not reported

  6. Registry updated

    May 15, 2026

Outcomes

What the study measures.

Primary outcomes

MACE

Time frame · through study completion, an average of 1 year

Myocardial Infarction, Ischemic Stroke, Cardiovascular mortality

Modified MACE

Time frame · through study completion, an average of 1 year

Myocardial Infarction, Ischemic Stroke, All-Cause mortality

Hospitalization for Heart Failure (HHF) Hospitalization for Heart Failure (HHF)

Time frame · through study completion, an average of 1 year

Secondary outcomes

Myocardial Infarction (MI)

Time frame · through study completion, an average of 1 year

Stroke

Time frame · through study completion, an average of 1 year

Cardiovascular Mortality

Time frame · through study completion, an average of 1 year

All-cause mortality

Time frame · through study completion, an average of 1 year

Coronary revascularization

Time frame · through study completion, an average of 1 year

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Age ≥ 18 years for Optum Cliniformatics, IBM Marketscan, CPRD, and VHA, and ≥ 65 years for Medicare FFS at cohort entry * At least 12 months of continuous health plan enrollment (only claims) or registration with a general practitioner (CPRD) before and including cohort entry * Diagnosis of T2D within 12 months before (or ever before in CPRD) and including cohort entry * Low or moderate cardiovascular (CV) risk (≤3% risk of CV events/year) at cohort entry \* * Metformin maintenance therapy, defined as 2 fills (or prescriptions in CPRD) of metformin monotherapy recorded within 6 months before and including cohort entry Exclusion Criteria: * Missing age or gender information * Nursing care admission within 12 months before and including cohort entry (criteria ignored in CPRD) * Diagnosis of type 1 diabetes within 12 months before and including cohort entry * Diagnosis of secondary or gestational diabetes within 12 months before and including cohort entry * Any insulin fill or prescription within 12 months before and including cohort entry * Diagnosis of end stage renal disease (stage ≥ 5) within 12 months before and including cohort entry * Diagnosis of acute or chronic pancreatitis within 12 months before and including cohort entry * Diagnosis of cirrhosis or acute hepatitis within 12 months before and including cohort entry * Diagnosis of MEN-2 within 12 months before and including cohort entry * Recorded solid organ transplant code within 12 months before and including cohort entry * Patients with recorded initiation of more than one agent within a comparator class at cohort entry

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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