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)

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2, Obesity

In brief

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.

Key facts

Study ID: NCT05514535
Run by: Novo Nordisk A/S
People needed: 573
Starts: 2022-08-29
Expected to finish: 2025-04-09
Last updated by the study team: 2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Lenzmeier Fam Med CCT Research — Glendale, Arizona, United States
Synexus Clinical Research US, Inc./Desert Clinical Research, — Mesa, Arizona, United States
OneLife Direct Care Inc. — Searcy, Arkansas, United States
Unity Health-Searcy Medical Center — Searcy, Arkansas, United States
San Fernando Valley Hlth Inst, LLC — Canoga Park, California, United States
Velocity Clin Res-Chula Vista — Chula Vista, California, United States
John Muir Physicians Network — Concord, California, United States
Valley Research — Fresno, California, United States
Ascada Research — Fullerton, California, United States
Providence Medical Foundation — Fullerton, California, United States
Velocity Clinical Research Huntington Park — Huntington Park, California, United States
Scripps Memorial Hospital La Jolla — La Jolla, California, United States
Velocity Clin Res San Diego — La Mesa, California, United States
First Valley Medical Group — Lancaster, California, United States
Loma Linda Univ Hlth Cr Endo — Loma Linda, California, United States
Torrance Clin Res Inst, Inc. — Lomita, California, United States
NRC Research Institute — Los Angeles, California, United States
Downtown LA Res Ctr. Inc. — Los Angeles, California, United States
Velocity Clin Res Los Angeles — Los Angeles, California, United States
Valley Clinical Trials, Inc. — Northridge, California, United States
San Diego Family Care_San Diego — San Diego, California, United States
Wetlin Research Associates, Inc. — San Diego, California, United States
University Clin Investigators — Tustin, California, United States
Velocity Clin Res, Denver — Denver, Colorado, United States
Shoals Primary Care — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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