DelfaGLP-1 Atlas

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CompletedPhase 3

A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

39

Recruiting sites

—

Enrollment

148

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10.5%

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 IDNCT05813912
Org study IDNN1436-4910
Secondary ID2022-002847-24
Secondary IDU1111-1281-4752World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-04-14actual
Study start2023-09-22actual
Primary completion2025-04-14actual
Study completion2025-05-16actual
Last update posted2026-04-09actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes (T2D) greater than or equal to (>=) 180 days prior to the day of screening
•HbA1c from 7.5%-10.5% (58-91 millimoles per mole [mmol/mol]) (both inclusive)
•Treated with once daily or twice daily basal insulin (minimum of 0.25 international units per kilograms per day (IU/kg/day) or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RA) >= 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses >= 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT2) inhibitors, thiazolidinediones, alpha-glucosidase inhibitors. Oral combination products (for the allowed individual oral anti-diabetic drugs)

Exclusion criteria

•Presence or history of pancreatitis (acute or chronic) within 180 days before screening
•Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and initiation
•Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
•Planned coronary, carotid or peripheral artery revascularization
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Endpoints (9)

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
5
Safety / tolerability / PK
3
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in mean post-prandial glucose increment (over all meals)

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Relative change in weekly insulin icodec dose

Time frame:From the week prior to intensification, week 25 (visit 27) to week 52 (visit 54)

percent change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Number of severe hypoglycaemic episodes (level 3)

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 mmol/L [54 milligrams per deciliter {mg/dL}], confirmed by blood glucose [BG] meter)

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL]), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)

Time frame:From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe 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.