DelfaGLP-1 Atlas

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E-SEMPA

RecruitingPhase 4

Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes

Effect of Early Combination Antihyperglycemic Treatment With Metformin and Oral Semaglutide vs. Metformin and Empagliflozin on Glycemic and Metabolic Control in Individuals With Short Duration Type 2 Diabetes

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

90

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤8%

Primary endpoint

•CGM time-in-range

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 IDNCT06613854
Org study IDE-SEMPA
Secondary ID0120-70/2024-2711-3National Medical Ethics Committee of the Republic of Slovenia

Timeline

Milestones

Study first posted2024-09-26actual
Study start2024-10-01actual
Last update posted2026-04-30actual
Primary completion2027-09estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes for up to 2 years (prior to randomization);
•Aged between 18 and 70 years, both sexes, of any race or ethnicity;
•HbA1c ≤8.0% at randomization;
•Baseline treatment with metformin at a steady daily dose of ≥1500 mg;
•Signed informed consent to participate in the study.

Exclusion criteria

•Treatment at any time in the past with SGLT2i, GLP-1RA, or DPP-4 inhibitors;
•Insulin treatment for longer than 2 weeks in the past;
•Body Mass Index below 22 kg/m2 or BMI above 40 kg/m2;
•Chronic kidney disease stages 3-5 (eGFR below 60 ml/min or the presence of albuminuria (urine albumin-to-creatinine ratio above 34 g/mmol);
•Known cardiovascular disease (angina pectoris, history of myocardial infarction, ischemic heart disease, heart failure, known carotid atherosclerosis, objectively proven peripheral arterial disease, or other known atherosclerotic disease at other locations);
•Moderate or severe liver disease (Child-Pugh stage B or C);
•Personal history of pancreatitis;
•Advanced heart failure (NYHA III-IV);
•Retinopathy or maculopathy or their active treatment;
•Pregnancy, expected pregnancy, or breastfeeding;
•Presence of active malignancy or personal history of malignancy within 5 years of study enrollment;
•Personal history of thyroid cancer; personal or family history of multiple endocrine neoplasia type 2 or family history of medullary thyroid carcinoma;
•Chronic inflammatory bowel disease;
•History of bariatric surgery or other gastrointestinal surgery that could affect drug or nutrient absorption;
•Frequent or severe urinary tract infections;
•Presence of a urinary catheter;
•Troublesome and recurrent genital fungal infections;
•Personal history of ketoacidosis;
•Symptomatic hypotension or predisposition to hypovolemia;
•History of organ transplantation;
•Allergy to any component in the semaglutide or empagliflozin oral tablet;
•Any medical or social circumstance that may limit participation in the study (e.g., inability to attend regular study visits);
•Any other condition that, in the opinion of the principal and responsible investigators, may affect the safety or efficacy of the treatment.

Endpoints (63)

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
24
Other (unclassified)
19
Cardiometabolic biomarkers
11
Weight & body composition
6
Safety / tolerability / PK
3

Weight & body composition

6 endpoints
Other/protocol endpoint

Change in Body Weight

Time frame:Baseline (week 0) and last study visit (week 26)

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Proportion of participants with a reduction of Body Weight above or equal to 5%

Time frame:Baseline (week 0) and last study visit (week 26)

≥5% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Proportion of participants with a reduction of Body Weight above or equal to 10%

Time frame:Baseline (week 0) and last study visit (week 26)

≥10% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Change in Waist Circumference

Time frame:Baseline (week 0) and last study visit (week 26)

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Change in Visceral Adipose Tissue Mass

Time frame:Baseline (week 0) and last study visit (week 26)

Visceral fat, change

change from baseline, improvement

Other/protocol endpoint

Change in the Proportion of the Total Body Fat Mass

Time frame:Baseline (week 0) and last study visit (week 26)

Total fat mass

percent change from baseline, improvement

Glycemic / diabetes

24 endpoints
Primary/protocol endpoint

Time in Range (TIR)

Time frame:Period of 14 days prior to last study visit (week 26)

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Absolute Change in Time in Range (TIR)

Time frame:Baseline (week 0) and last study visit (week 26)

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Glycated hemoglobin (HbA1c)

Time frame:Baseline (week 0) and last study visit (week 26)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time above Range (TAR)

Time frame:Last study visit (week 26)

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Time below Range (TBR)

Time frame:Last study visit (week 26)

CGM time-below-range

descriptive, improvement

Secondary/protocol endpoint

Time above Range (TAR) - Level 1 Hyperglycemia

Time frame:Last study visit (week 26)

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Time above Range (TAR) - Level 2 Hyperglycemia

Time frame:Last study visit (week 26)

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Time below Range (TBR) - Level 1 Hypoglycemia

Time frame:Last study visit (week 26)

CGM time-below-range

descriptive, improvement

Secondary/protocol endpoint

Time below Range (TBR) - Level 2 Hypoglycemia

Time frame:Last study visit (week 26)

CGM time-below-range

descriptive, improvement

Secondary/protocol endpoint

Time in Tight Range (TITR)

Time frame:Last study visit (week 26)

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Coefficient of variation (CV)

Time frame:Last study visit (week 26)

ratio, improvement

Secondary/protocol endpoint

Mean Time in Range (TIR)

Time frame:Study visit at week 13 and week 26

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Mean glucose concentration

Time frame:Last study visit (week 26)

descriptive, improvement

Secondary/protocol endpoint

Proportion of participants with Coefficient of variation (CV) below or equal to 36%

Time frame:Last study visit (week 26)

threshold achievement, improvement

Secondary/protocol endpoint

Standard deviation of mean glucose concentration

Time frame:Last study visit (week 26)

descriptive, improvement

Secondary/protocol endpoint

Proportion of participants with Time in Range (TIR) above 70%

Time frame:Last study visit (week 26)

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants with Time in Range (TIR) above 90%

Time frame:Last study visit (week 26)

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants with Glycated hemoglobin (HbA1c) below 6.5%

Time frame:Last study visit (week 26)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of participants with Glycated hemoglobin (HbA1c) below 5.7%

Time frame:Last study visit (week 26)

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of participants requiring rescue therapy with gliclazide

Time frame:Baseline (week 0) to last study visit (week 26)

threshold achievement, improvement

Other/protocol endpoint

Change of Insulin Resistance - Matsuda Index

Time frame:Baseline (week 0) and last study visit (week 26)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Change of Insulin Resistance - HOMA-IR

Time frame:Baseline (week 0) and last study visit (week 26)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Change of Insulin Sensitivity - HOMA2-%S

Time frame:Baseline (week 0) and last study visit (week 26)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Change of Pancreatic Beta Cell Function - HOMA2-%B

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Cardiometabolic biomarkers

11 endpoints
Other/protocol endpoint

Change in Concentration of Total Cholesterol (TC)

Time frame:Baseline (week 0) and last study visit (week 26)

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Other/protocol endpoint

Change in Concentration of High Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline (week 0) and last study visit (week 26)

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Other/protocol endpoint

Change in Concentration of Low Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline (week 0) and last study visit (week 26)

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Other/protocol endpoint

Change in Concentration of Triglycerides (TG)

Time frame:Baseline (week 0) and last study visit (week 26)

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

Change in Concentration of Apolipoprotein A1 (ApoA1)

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint

Change in Concentration of Apolipoprotein B (ApoB)

Time frame:Baseline (week 0) and last study visit (week 26)

ApoB, change

change from baseline, improvement

Other/protocol endpoint

Change in Concentration of Uric Acid

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint

Change in Concentration of 8-Isoprostane

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint

Change in Concentration of high-sensitivity C-reactive protein (hs-CRP)

Time frame:Baseline (week 0) and last study visit (week 26)

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other/protocol endpoint

Change in Concentration of Free Fatty Acids

Time frame:Baseline (week 0) and last study visit (week 26)

Free fatty acids, change

change from baseline, improvement

Other/protocol endpoint

Change in Concentration of Methionine

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Proportion of participants with severe hypoglycemia

Time frame:Baseline (week 0) to last study visit (week 26)

Severe hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Proportion of participants with severe adverse events

Time frame:Baseline (week 0) to last study visit (week 26)

Serious AEs (any)

threshold achievement, event

Secondary/protocol endpoint

Proportion of patients withdrawing from the trial due to adverse events of the interventional drugs

Time frame:Baseline (week 0) to last study visit (week 26)

Discontinuation due to AE

threshold achievement, event

Other (unclassified)

19 endpoints
Other/protocol endpoint/low confidence

Change in Total Antioxidant Status

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Glutathione Peroxidase Activity in Erythrocytes

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Superoxide Dismutase Activity in Erythrocytes

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Advanced Oxidation Protein Products (AOPP)

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Concentration of Advanced Glycosylation End Products (AGE)

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Concentration of Interleukin-6 (IL-6)

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Concentration of Beta-hydroxybutyrate

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Alanine

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Leucine

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Isoleucine

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Valine

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Phenylalanine

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Lysine

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Glutamate

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Concentration of Acylcarnitine C5

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Acylcarnitine C8:1

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Acylcarnitine C5-OH

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Acylcarnitine C4-OH

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Concentration of Acylcarnitine C4-DC

Time frame:Baseline (week 0) and last study visit (week 26)

change from baseline, 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.