DelfaGLP-1 Atlas

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CompletedPhase 3

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

182

Recruiting sites

—

Enrollment

679

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤40•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 IDNCT05013229
Org study IDNN1535-4593
Secondary ID2020-005309-18
Secondary IDjRCT2051210127JAPIC
Secondary IDU1111-1260-8295WHO

Timeline

Milestones

Study first posted2021-08-19actual
Study start2021-11-30actual
Primary completion2023-11-14actual
Study completion2023-11-14actual
Last update posted2025-12-02actual

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

•Male or female and age above or equal to 18 years at the time of signing informed consent.
•Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
•HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
•Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses 90 days or more before screening:
–Metformin
–Sulfonylureas(a)
–Meglitinides (glinides)(a)
–DPP-4 inhibitors(a)
–Sodium-glucose co-transporter 2 inhibitors
–Alpha-glucosidase-inhibitors
–Thiazolidinediones
–Marketed oral combination products only including the products listed above.
•Body mass index (BMI) less than or equal to 40.0 kg/m^2.

1. Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation.

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
•Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid, hormones, or systemic corticosteroids).
•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
•Any episodes of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records.
•Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
•Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
•Chronic heart failure classified as being in New York Heart Association Class IV at screening.
•Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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.

Endpoints (11)

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
6
Safety / tolerability / PK
3
Weight & body composition
1
Patient-reported / QoL
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:From baseline week 0 (V2) to week 52 (V54)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:From baseline week 0 (V2) to week 52 (V54)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6

Time frame:From week 48 (V50) to week 52 (V54)

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6

Time frame:From week 48 (V50) to week 52 (V54)

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6

Time frame:From week 48 (V50) to week 52 (V54)

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline week 0 (V2) to week 52 (V54)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Weekly insulin dose (total)

Time frame:From week 50 (V52) to week 52 (V54)

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction

Time frame:From baseline week 0 (V2) to week 52 (V54)

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

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

Time frame:From week 0 (V52) to week 52 (V54)

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Secondary/protocol endpoint

Number of severe hypoglycaemic episodes (level 3)

Time frame:From baseline week 0 (V2) to week 57 (V56)

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter)

Time frame:From baseline week 0 (V2) to week 57 (V56)

Documented hypoglycemia

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.