Phase 3
N=573
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)
Diabetes Mellitus, Type 2 · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05514535 ↗Enrolled (actual)
573
Serious AEs
5.6%
Results posted
May 2026
Primary outcome: Primary: Change in Glycated Haemoglobin (HbA1c) [Noninferiority] — -1.37; -0.65 Percentage point of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide (Drug); Insuline glargine U100 (reduced) (Drug); Insuline glargine U100 (titrated) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Haemoglobin (HbA1c) [Noninferiority] |
-1.37; -0.65 | — |
| SECONDARY Change in Body Weight |
-7.97; 0.39 | — |
| SECONDARY Percentage Change in Daily Insulin Dose |
-15.11; 103.42 | — |
| SECONDARY Change in Glycated Haemoglobin (HbA1c ) [Superiority] |
-1.37; -0.65 | — |
| SECONDARY Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) |
14.69; 12.11 | — |
| SECONDARY Number of Participants Achieving Insulin Dose = 0 Units/mL (U) |
37; 0 | — |
| SECONDARY Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50% |
103; 2 | — |
| SECONDARY Number of Participants Achieving HbA1c Less Than (<) 7% |
224; 111 | — |
| SECONDARY Number of Severe Hypoglycaemic Episodes (Level 3) |
6; 14 | — |
| SECONDARY Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter) |
16; 32 | — |
| SECONDARY 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) |
22; 46 | — |
| SECONDARY 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 |
138; 6 | — |
| SECONDARY Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs) |
4.56; 2.17 | — |
| SECONDARY Change in Score of Short Form 36 Version 2 (SF-36 v2) |
3.18; 0.12; 1.63; 0.93 | — |
Summary
This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.
Eligibility Criteria
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 ( =) 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.
Data sourced from ClinicalTrials.gov (NCT05514535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.