GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

Efficacy and Safety of Once-weekly Semaglutide S.C. 2.0 mg as Add-on to Dose-reduced Insulin Glargine vs Titrated Insulin Glargine in Participants With Type 2 Diabetes and Overweight

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

239

Recruiting sites

—

Enrollment

573

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoints

•Glycated Haemoglobin (HbA1c) [Noninferiority]•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 IDNCT05514535

Org study IDNN9535-4801

Secondary ID2021-004392-13

Secondary IDU1111-1267-0312World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-08-24actual

Study start2022-08-29actual

Primary completion2025-03-05actual

Study completion2025-04-09actual

Last update posted2026-05-11actual

Results first posted2026-05-11actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with Type 2 Diabetes Mellitus (T2D) mellitus greater than or equal to (>=) 180 days before screening.

•Glycated haemoglobin (HbA1c) of 7-10 percentage [(53-86 millimoles per mole (mmol/mol)] (both inclusive) as assessed by central laboratory on the day of screening.

•Body mass index (BMI) greater than or equal to (>=) 25 kilograms per meter square (kg/m^2) on the day of screening.

•Stable daily dose(s) greater than or equal to (>=) 90 days before screening of any of the following anti-diabetic drugs or combination regimens:

•Any metformin formulations greater than or equal to (>=) 1500 milligrams (mg) or maximum tolerated or effective dose.

•Any metformin combination formulation greater than or equal to (>=) 1500 mg or maximum tolerated or effective dose.

The treatment can be with or without sodium glucose cotransporter 2 (SGLT-2) inhibitors.

• Treated with a once daily basal insulin (e.g. insulin glargine Unit 100 or U300, neutral protamine hagedorn (NPH) insulin, insulin detemir, insulin degludec) less than or equal to (<=) 40 units/day (U/day) for greater than or equal to (>=) 90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed.

Exclusion criteria

•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.

•Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.26 nanomoles per litre (nmol/L) (or 260 picomoles per liter [pmol/L] [0.78 nanograms per millilitre {ng/mL}]) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/millilitre, as measured by the central laboratory at screening.

•Presence or history of pancreatitis (acute or chronic).

•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 millilitre per minute per 1.73 meter square at screening as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 classification.

•Any episodes of diabetic ketoacidosis within 90 days before screening.

•Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.

Endpoints (28)

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

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

3 endpoints

Secondary/registry result

Change in Body Weight

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	-7.97	—
Insuline Glargine U100 (Titrated)	0.39	—

Secondary/registry result

Number of Participants Achieving HbA1c Reduced From Baseline by at Least 0.3%-Points and Insulin Dose Reduced From Baseline, No Hypoglycaemic Episodes (< 3.9 mmol/L (70 mg/dL) Confirmed by BG Meter) and No Weight Gain

Time frame:At end of treatment (week 40)

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	138	—
Insuline Glargine U100 (Titrated)	6	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:From baseline (week 0) to end of treatment (week 40)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

16 endpoints

Primary/registry result

Change in Glycated Haemoglobin (HbA1c) [Noninferiority]

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Posted result

Group	Value (mean), Percentage point of HbA1c	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	-1.37	—
Insuline Glargine U100 (Titrated)	-0.65	—

Primary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c) [Noninferiority]

Time frame:From baseline (week 0) to end of treatment (week 40)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage Change in Daily Insulin Dose

Time frame:From baseline (week 0) to end of treatment (week 40)

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change of daily insulin dose	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	-15.11	—
Insuline Glargine U100 (Titrated)	103.42	—

Secondary/registry result

Change in Glycated Haemoglobin (HbA1c ) [Superiority]

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Posted result

Group	Value (mean), Percentage-point of HbA1c	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	-1.37	—
Insuline Glargine U100 (Titrated)	-0.65	—

Secondary/registry result

Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)

Time frame:At end of treatment (week 40)

descriptive

Posted result

Group	Value (mean), Score on a scale	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	14.69	—
Insuline Glargine U100 (Titrated)	12.11	—

Secondary/registry result

Number of Participants Achieving Insulin Dose = 0 Units/mL (U)

Time frame:At end of treatment (week 40)

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	37	—
Insuline Glargine U100 (Titrated)	0	—

Secondary/registry result

Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50%

Time frame:At end of treatment (week 40)

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	103	—
Insuline Glargine U100 (Titrated)	2	—

Secondary/registry result

Number of Participants Achieving HbA1c Less Than (<) 7%

Time frame:At end of treatment (week 40)

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	224	—
Insuline Glargine U100 (Titrated)	111	—

Secondary/registry result

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)

Time frame:From baseline (week 0) to end of treatment (week 40)

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	16	—
Insuline Glargine U100 (Titrated)	32	—

Secondary/registry result

Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Posted result

Group	Value (mean), Score on scale	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	4.56	—
Insuline Glargine U100 (Titrated)	2.17	—

Secondary/protocol endpoint

Percentage Change in Daily Insulin Dose

Time frame:From baseline (week 0) to end of treatment (week 40)

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c ) [Superiority]

Time frame:From baseline (week 0) to end of treatment (week 40)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Achieving Insulin Dose = 0 Units/mL (U)

Time frame:At end of treatment (week 40)

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50%

Time frame:At end of treatment (week 40)

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving HbA1c Less Than (<) 7%

Time frame:At end of treatment (week 40)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Time frame:At end of treatment (week 40)

threshold achievement, improvement

componentsHbA1c, change, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change in Score of Short Form 36 Version 2 (SF-36 v2)

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Insuline Glargine U100 (Reduced) + SemaglutidePhysical Component Score	3.18	—
Mental Component Score	1.63	—
Insuline Glargine U100 (Titrated)Physical Component Score	0.12	—
Mental Component Score	0.93	—

Secondary/protocol endpoint

Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)

Time frame:At end of treatment (week 40)

change from baseline, improvement

Secondary/protocol endpoint

Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Secondary/protocol endpoint

Change in Score of Short Form 36 Version 2 (SF-36 v2)

Time frame:From baseline (week 0) to end of treatment (week 40)

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/registry result

Number of Severe Hypoglycaemic Episodes (Level 3)

Time frame:From baseline (week 0) to end of treatment (week 40)

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	6	—
Insuline Glargine U100 (Titrated)	14	—

Secondary/registry result

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 (week 0) to end of treatment (week 40)

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insuline Glargine U100 (Reduced) + Semaglutide	22	—
Insuline Glargine U100 (Titrated)	46	—

Secondary/protocol endpoint

Number of Severe Hypoglycaemic Episodes (Level 3)

Time frame:From baseline (week 0) to end of treatment (week 40)

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)

Time frame:From baseline (week 0) to end of treatment (week 40)

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 (week 0) to end of treatment (week 40)

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 tableClinicalTrials.gov results section

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.