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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) | Clinical Trials | Clareo Health

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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

NCT05514535•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (157)

Lenzmeier Fam Med CCT Research

Glendale, Arizona, United States

San Fernando Valley Hlth Inst, LLC

Canoga Park, California, United States

John Muir Physicians Network

Concord, California, United States

Valley Research

Fresno, California, United States

Providence Medical Foundation

Fullerton, California, United States

Velocity Clinical Research Huntington Park

Huntington Park, 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

Downtown LA Res Ctr. Inc.

Los Angeles, California, United States

Key Dates

Start Date

August 29, 2022

Primary Completion Date

March 5, 2025

Completion Date

April 9, 2025

Last Updated

November 25, 2025

Enrollment

568

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Semaglutide

DRUG

Insuline glargine U100 (reduced)

DRUG

Insuline glargine U100 (titrated)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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