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NCT05514535

PHASE3

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)

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

573

Start Date

2022-08-29

Completion Date

2025-04-09

Last Updated

2026-05-11

Healthy Volunteers

Conditions

Diabetes Mellitus, Type 2 Obesity

Interventions

DRUG

Semaglutide

Participants will receive once-weekly semaglutide s.c. for 40 weeks. Semaglutide 0.25 mg will be given at week 0 and then the dose will be escalated at weeks 4, 8 and 12 to 0.5 mg, 1 mg, 2 mg respectively.

DRUG

Insuline glargine U100 (reduced)

Participants will receive insulin glargine U100 s.c. once-daily. Insulin glargine dose will be reduced by 10 U at initiation of semaglutide and then again at each semaglutide dose escalation up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).

DRUG

Insuline glargine U100 (titrated)

Participants will receive titrated insulin glargine U100 s.c. once-daily up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).

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 (239)

Shoals Primary Care

Sheffield, Alabama, United States

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

Chase Medical Research LLC

Waterbury, Connecticut, United States

Indago Research & Health Center Inc.

Hialeah, Florida, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Northeast Res Inst. Inc.

Jacksonville, Florida, United States

Jacksonville Ctr For Clin Res

Jacksonville, Florida, United States

Care-Partners-Clinical-Research, LLC

Jacksonville, Florida, United States

Suncoast Research Group, LLC

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Elite Research Center

Miami, Florida, United States

Diverse Clinical Research Miami

Miami, Florida, United States

Reyes Clinical Research, Inc

Miami, Florida, United States

International Research Associates, LLC_Miami

Miami, Florida, United States

South Broward Research LLC

Miramar, Florida, United States

Suncoast Clin Res Port Richey

New Port Richey, Florida, United States

Suncoast Clinical Research, Inc._New Port Richey

New Port Richey, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Clinical Research Trials of Florida

Tampa, Florida, United States

CVS Store Number: 7689

Atlanta, Georgia, United States

East Coast Institute for Res

Canton, Georgia, United States

Coastal Heritage Clinical Research

Hinesville, Georgia, United States

East Coast Institute for Res

Macon, Georgia, United States

Endocrine Research Solutions

Roswell, Georgia, United States

CVS Store Number: 05520

Savannah, Georgia, United States

Solaris Clinical Research

Meridian, Idaho, United States

Cedar-Crosse Research Center

Chicago, Illinois, United States

WellNow Urgent Care

Chicago, Illinois, United States

Brengle Family Medicine

Indianapolis, Indiana, United States

West Broadway Clinic

Council Bluffs, Iowa, United States

Iowa Diab & Endo Res Center

West Des Moines, Iowa, United States

Iowa Diab & Endo Res Center

West Des Moines, Iowa, United States

Cotton O'Neil Diab & Endo Ctr

Topeka, Kansas, United States

The Research Group of Lexington LLC

Lexington, Kentucky, United States

L-MARC Research Center

Louisville, Kentucky, United States

Arthritis And Diabetes Clinic, Inc.

Monroe, Louisiana, United States

AMR New Orleans

New Orleans, Louisiana, United States

Ileana J. Tandron, MD APMC (a private medical office)

Slidell, Louisiana, United States

MedStar Hlth Res Institute

Hyattsville, Maryland, United States

Endo And Metab Cons

Rockville, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Northern Pines Hlth Ctr, PC

Buckley, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Elite Research Center

Flint, Michigan, United States

Arcturus HC PLC Troy Med Res

Troy, Michigan, United States

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

Mercury Str Med Grp, PLLC

Butte, Montana, United States

Clinical Research Advantage, Inc./Skyline Medical Center, PC

Elkhorn, Nebraska, United States

Methodist Physicians Clinic

Fremont, Nebraska, United States

Velocity Clin Res, Norfolk

Norfolk, Nebraska, United States

Midwest Regional Health Services

Omaha, Nebraska, United States

Univ of Nebraska Medical CTR

Omaha, Nebraska, United States

Palm Research Center Inc-Vegas

Las Vegas, Nevada, United States

Southern New Hampshire Diabetes and Endocrinology

Nashua, New Hampshire, United States

Premier Research Inc.

Trenton, New Jersey, United States

AMC Community Endocrinology

Albany, New York, United States

Dr. Alexander Perkelvald

Brooklyn, New York, United States

Mid Hudson Med Res-New Windsor

New Windsor, New York, United States

Great Lakes Medical Research

Westfield, New York, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Physicians East Endocrinology

Greenville, North Carolina, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Centricity Rsrch MHCity Multi

Morehead City, North Carolina, United States

Lillestol Research LLC

Fargo, North Dakota, United States

Velocity Clin Res Cleveland

Beachwood, Ohio, United States

Diab & Endo Assoc of Stark Co

Canton, Ohio, United States

Velocity Clin Res_Cincinnati

Cincinnati, Ohio, United States

Albert J Weisbrot

Mason, Ohio, United States

Advanced Med Res Maumee

Maumee, Ohio, United States

University of Toledo Medical Center

Toledo, Ohio, United States

University of Toledo_Toledo

Toledo, Ohio, United States

Intend Research

Norman, Oklahoma, United States

Lynn Institute of Norman

Norman, Oklahoma, United States

Velocity Clinical Res Medford

Medford, Oregon, United States

Heritage Valley Multispeciality Group Inc

Beaver, Pennsylvania, United States

Richard M Kastelic MD Assoc

Johnstown, Pennsylvania, United States

And 139 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (239)