DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06083675

WithdrawnPhase 3

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Efficacy and Safety of First Line Use of Oral Semaglutide 25 mg or 50 mg Once Daily Versus Empagliflozin 25 mg or Versus Metformin 2000 mg in Newly Diagnosed Treatment naïve Patients With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

100

Recruiting sites

—

Enrollment

—

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7-10%

Primary endpoint

•HbA1c, change

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 IDNCT06083675
Org study IDNN9924-7663
Secondary IDU1111-1291-4976World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-10-16actual
Study start2024-01-26estimated
Last update posted2024-02-26actual
Primary completion2025-01-24estimated
Study completion2027-05-28estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female.
•Age ≥18 and <60 years at the time of signing the informed consent.
•Diagnosed with type 2 diabetes mellitus within 24 months from the day of screening.
•HbA1c of 7.0-10.0% (53-86 millimoles per mole [mmol/mol])
•Body mass index ≥25.0 kilogram per square meter (kg/m^2)

Exclusion criteria

•Treatment with any medication for the indication of diabetes. Prior insulin treatment for gestational diabetes is allowed.
•Treatment with any medication for the indication of weight management 90 days prior to screening.
•Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 meter sqaure (mL/min/1.73 m^2) at screening.
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
•C-peptide <1.5 nanograms per milliliter (ng/mL) at screening.
•Positive insulinoma associated-protein 2 (IA-2) antibodies ≥7.5 Units/mL or anti-glutamic acid decarboxylase (anti-GAD) antibodies greater than (>) 5.0 international units per milliliter (IU/mL).
•Impaired liver function, defined as Alanine aminotransferase (ALT) ≥2.5 times or Bilirubin >1.5 times upper normal limit at screening.
•History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
•Presence of clinically significant gastrointestinal disorders affecting absorption of drugs and/or nutrients, as judged by the investigator.
•Any contraindications for empagliflozin or metformin according to local labelling at the investigator's discretion

Endpoints (45)

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
15
Weight & body composition
12
Cardiometabolic biomarkers
8
Patient-reported / QoL
6
Safety / tolerability / PK
4

Weight & body composition

12 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:From randomisation (week 0) to week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:From randomisation (week 0) to week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From randomisation (week 0) to week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Body weight reduction greater than equal to ( ≥) 5% (Yes/No)

Time frame:At week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body weight reduction ≥10% (Yes/No)

Time frame:At week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body weight reduction ≥15% (Yes/No)

Time frame:At week 52

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From randomisation (week 0) to week 104

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:From randomisation (week 0) to week 104

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From randomisation (week 0) to week 104

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Body weight reduction ≥5% (Yes/No)

Time frame:At week 104

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body weight reduction ≥10% (Yes/No)

Time frame:At week 104

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body weight reduction ≥15% (Yes/No)

Time frame:At week 104

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

15 endpoints
Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From randomisation (week 0) to week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From randomisation (week 0) to week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in 7 point self measured plasma glucose (SMPG) mean profile

Time frame:From randomisation (week 0) to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments

Time frame:From randomisation (week 0) to week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

HbA1c less than or equal to (≤) 6.5% (Yes/No)

Time frame:At week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c less than (<) 7% (Yes/No)

Time frame:At week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c <7.0% and body weight reduction ≥5% (Yes/No)

Time frame:At week 52

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

Secondary/protocol endpoint/low confidence

Time to rescue medication

Time frame:From randomisation (week 0) to week 104

time to event, event

Secondary/protocol endpoint

Change in HbA1c

Time frame:From randomisation (week 0) to week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:From randomisation (week 0) to week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in 7 point SMPG mean profile

Time frame:From randomisation (week 0) to week 104

change from baseline, improvement

Secondary/protocol endpoint

Change in 7-point SMPG mean post prandial increments

Time frame:From randomisation (week 0) to week 104

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

HbA1c ≤6.5% (Yes/No)

Time frame:At week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c <7.0% (Yes/No)

Time frame:At week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c <7.0% and body weight reduction ≥5% (Yes/No)

Time frame:At week 104

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From randomisation (week 0) to week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:From randomisation (week 0) to week 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in High-sensitivity C-reactive protein (hsCRP)

Time frame:From randomisation (week 0) to week 52

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From randomisation (week 0) to week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:From randomisation (week 0) to week 104

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in hsCRP

Time frame:From randomisation (week 0) to week 104

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in American Heart Association (AHA) Life's Simple 7 summary score

Time frame:From randomisation (week 0) to week 52

change from baseline, improvement

componentsBMI, change, Total cholesterol, change, Systolic BP, change, Diastolic BP, change, Fasting glucose, change

Secondary/protocol endpoint

Change in AHA Life's Simple 7 summary score

Time frame:From randomisation (week 0) to week 104

change from baseline, improvement

Patient-reported / QoL

6 endpoints
Secondary/protocol endpoint

Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain

Time frame:From randomisation (week 0) to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ score - Craving for Savory domain

Time frame:From randomisation (week 0) to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain

Time frame:From randomisation (week 0) to week 52

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ score - Craving Control domain

Time frame:From randomisation (week 0) to week 104

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ score - Craving for Savory domain

Time frame:From randomisation (week 0) to week 104

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT score - Physical function domain

Time frame:From randomisation (week 0) to week 104

IWQOL-Lite physical

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Treatment emergent adverse events

Time frame:From randomisation (week 0) to week 52

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes

Time frame:From randomisation (week 0) to week 52

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Treatment emergent adverse events

Time frame:From randomisation (week 0) to follow-up visit (week 109)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes

Time frame:From randomisation (week 0) to follow-up visit (week 109)

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

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.