DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT03921242

Completed

Comparative Effectiveness of Metformin for Type 2 Diabetes With Chronic Kidney Disease

Asset

GLP-1 / incretin class catch-all

Listed sites

2

Recruiting sites

—

Enrollment

4,888

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•HbA1c ≥6.5%•eGFR ≤60

Primary endpoints

•Severe hypoglycemia•HbA1c, change•Heterogeneity of Treatment Effect

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03921242
Org study ID1809019555

Timeline

Milestones

Study first posted2019-04-19actual
Study start2019-08-01actual
Primary completion2023-08-01actual
Study completion2023-08-01actual
Last update posted2023-11-09actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

EHR data from two data sources (NYC and Mid-South CDRN's) will be linked to insurance claims data to identify adult patients (age \> 18) with T2DM and CKD, who are initiating metformin or one of the comparator drugs. Also, participants will further be required to have at least one prescription for metformin, sulfonylurea, or DPP-4 inhibitor; at least 6 months preceding that prescription in which none of those drugs are used; and an eGFR within 1 month prior to the index date (the date on which the drug of interest is started) of \< 60 mL/min

Inclusion criteria

•A coded inpatient or outpatient T2DM diagnosis (ICD9/ICD10) and an antidiabetic medication prescription within the 90 days following the diagnosis date (CP1); a coded T2DM diagnosis and an outpatient glycolated hemoglobin (HbA1C) value≥6.5% within 90 days before or after the diagnosis date (CP2); or any antidiabetic medication prescription within 90 days before or after an outpatient HbA1C value ≥6.5% (CP3).
•New use of a medication of interest (metformin, sulfonylurea, DPP4 inhibitor, SGLT2 inhibitor, or GLP1 receptor agonist
•Estimated glomerular filtration rate (eGFR) of less than 60 ml/min within the month prior to the new medication

Exclusion criteria

•Coded diagnoses of gestational diabetes
•Coded diagnoses of prediabetes
•Coded diagnoses of type 1 diabetes
•Evidence of a positive beta human chorionic gonadotropin test as a marker for pregnancy during the 90 days before or after the index date

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Safety / tolerability / PK
2
Weight & body composition
1
Renal / kidney
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Difference in Body-Mass Index Assessed From EMR (BMI) (kg/m2)

Time frame:24 Months

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Difference in Glycosylated Hemoglobin (HbA1c) level (mmol/mol)

Time frame:24 Months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Difference in Glycosylated Hemoglobin (HbA1c) level (mmol/mol)

Time frame:24 Months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Difference in Laboratory-Measured eGFR (mL/min)

Time frame:24 Months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Incidence of Severe Hypoglycemia Assessed from EMR

Time frame:18 Months

Severe hypoglycemia

time to event, event

Secondary/protocol endpoint/low confidence

Incidence of acidosis, hospitalization for hyperglycemia, acute myocardial infarction, stroke, heart failure hospitalization, and heart failure emergency room visits

Time frame:18 Months

time to event, event

componentsMyocardial infarction (any), Stroke (any), Heart-failure hospitalization, Urgent heart-failure visit

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Heterogeneity of Treatment Effect Via Pre-specified Sub-Group Analyses

Time frame:25 Months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.