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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide; Drug: Insuline glargine U100 (reduced); Drug: Insuline glargine U100 (titrated)

• Study Type: Interventional
• Enrollment (Estimated): 568
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Czechia
  • Nachod, Czechia, 547 01
    • Recruiting
    • EDUMED s.r.o. Nachod
  • Pardubice 5, Czechia, 530 02
    • Recruiting
    • Diahelp - diabetologie
  • Plzen - Vychodni Predmesti, Czechia, 326 00
    • Recruiting
    • MUDr. Jitka Zemanova diabetologie a interna
  • Praha 1, Czechia, 110 00
    • Active, not recruiting
    • Diabet2 s.r.o.
  • Praha 4, Czechia, 140 00
    • Not yet recruiting
    • MUDr. Michala Pelikanova
  • Praha 4, Czechia, 140 00
    • Active, not recruiting
    • MUDr. Michala Pelikanova
  • Praha 8, Czechia, 18100
    • Recruiting
    • ResTrial s.r.o.
• Greece
  • Alexandroupolis, Greece, GR-68100
    • Recruiting
    • University Hospital of Alexandroupolis
  • Athens, Greece, GR-11527
    • Recruiting
    • "Laiko" General Hospital of Athens
  • Athens, Greece, GR-11528
    • Recruiting
    • Alexandra General Hospital, Therapeutic Clinic
  • Athens, Greece, GR-11528
    • Not yet recruiting
    • Alexandra General Hospital, Therapeutic Clinic
  • Haidari-Athens, Greece, GR-12462
    • Recruiting
    • University Hospital of Athens ATTIKON
  • Nikaia, Greece, GR-18454
    • Not yet recruiting
    • General Hospital of Nikaia
  • Piraeus, Greece, GR-18536
    • Not yet recruiting
    • Tzaneio General Hospital of Piraeus
  • Thessaloniki, Greece, GR-54643
    • Recruiting
    • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
  • Thessaloniki, Greece, GR-54636
    • Recruiting
    • AHEPA General University Hospital
  • Thessaloniki, Greece, GR-57001
    • Recruiting
    • "Thermi" Private Hosital
  • Thessaloniki, Greece, 54636
    • Recruiting
    • AHEPA General University Hospital
  • Thessaloniki, Greece, GR-57010
    • Not yet recruiting
    • General Hospital of Thessaloniki "G.Papanikolaou"
• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Catanzaro, Italy, 88100
    • Recruiting
    • Policlinico Mater Domini Università di Catanzaro
  • Montichiari, Italy, 25018
    • Recruiting
    • ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
  • Napoli, Italy, 80138
    • Recruiting
    • A.O.U. Università Studi della Campania "Luigi Vanvitelli"
  • Perugia, Italy, 06129
    • Recruiting
    • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
  • Rome, Italy, 00168
    • Recruiting
    • Policlinico A. Gemelli
  • LT
    • Latina, LT, Italy, 04100
      • Recruiting
      • Ospedale Santa Maria Goretti - UOD Diabetologia
  • LU
    • Lucca, LU, Italy, 55100
      • Recruiting
      • Ospedale Civile Campo di Marte
  • MI
    • Milano, MI, Italy, 20132
      • Recruiting
      • Istituto Scientifico San Raffaele
• Portugal
  • Almada, Portugal, 2805-267
    • Recruiting
    • Hospital Garcia de Orta
  • Aveiro, Portugal, 3814-501
    • Recruiting
    • Hospital Infante D. Pedro - Aveiro
  • Braga, Portugal, 4710-243
    • Recruiting
    • Hospital de Braga
  • Caldas da Rainha, Portugal, 2500-176
    • Recruiting
    • Centro Hospitalar do Oeste - Unidade Caldas de Rainha
  • Leiria, Portugal, 2410-197
    • Recruiting
    • Centro Hospitalar de Leiria EPE - Hospital de Santo André
  • Lisboa, Portugal, 1050-099
    • Recruiting
    • Centro Hospitalar Lisboa Central - Hospital Curry Cabral
  • Lisboa, Portugal, 1349-019
    • Recruiting
    • Centro Hospitalar Lisboa Ocidental
  • Matosinhos, Portugal, 4464-513
    • Recruiting
    • Unidade Local de Saúde de Matosinhos
  • Viana do Castelo, Portugal, 4904-858
    • Recruiting
    • Unidade Local de Saúde do Alto Minho - Viana do Castelo
• Romania
  • Braila, Romania, 810197
    • Not yet recruiting
    • Clinica Grivitei 224 S.R.L.
  • Brasov, Romania, 500283
    • Recruiting
    • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
  • Brasov, Romania, 500283
    • Not yet recruiting
    • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
  • Bucuresti, Romania, 040172
    • Recruiting
    • Diabs&Nutricare Srl
  • Constanta, Romania, 900591
    • Recruiting
    • Clinic of Diabetes Constanta
  • Constanta, Romania, 900591
    • Not yet recruiting
    • Clinic of Diabetes Constanta
  • Galati, Romania, 800578
    • Recruiting
    • Clinical Emergency Sf. Apostol Andrei Hospital
  • Iasi, Romania, 700547
    • Recruiting
    • SC Consultmed SRL
  • Oradea, Romania, 410001
    • Recruiting
    • Medical Practice SRL
  • Ploiesti, Romania, 100561
    • Not yet recruiting
    • S.C. Dianutrilife Medica S.R.L.
  • Satu-Mare, Romania, 440055
    • Recruiting
    • Clinica Korall S.R.L. Satu Mare
  • Targu Mures, Romania, 540098
    • Recruiting
    • Dentosim Queen Srl
  • Bihor
    • Oradea, Bihor, Romania, 410025
      • Recruiting
      • SC Grand Med SRL
  • Dambovita
    • Targoviste, Dambovita, Romania, 130083
      • Recruiting
      • Spitalul Judetean de Urgenta Targoviste
  • Maramures
    • Baia Mare, Maramures, Romania, 430222
      • Recruiting
      • CMI Dr Pop Lavinia
  • Prahova
    • Ploiesti, Prahova, Romania, 100018
      • Recruiting
      • Novus Medical Clinica SRL
  • Timis
    • Timisoara, Timis, Romania, 300125
      • Recruiting
      • Centrul Medical Sfantul Stefan
• Slovakia
  • Bojnice, Slovakia, 97201
    • Recruiting
    • DIA - CLARUS s.r.o.
  • Bratislava, Slovakia, 851 01
    • Recruiting
    • MEDISPEKTRUM s.r.o.
  • Bratislava, Slovakia, 83103
    • Recruiting
    • Diabetologicka ambulancia MediTask, s.r.o
  • Levice, Slovakia, 93401
    • Suspended
    • Diabetologicka ambulancia DIA-MAX s.r.o.
  • Lucenec, Slovakia, 984 01
    • Recruiting
    • Diabetologicka ambulancia IN-DIA s.r.o.
  • Nove Zamky, Slovakia, 940 59
    • Recruiting
    • Diabetologicka ambulancia FUNKYSTUFF s.r.o
  • Poprad, Slovakia, 05801
    • Recruiting
    • Diabetologicka ambulancia Diakom, spol. s r.o.
  • Presov, Slovakia, 080 01
    • Recruiting
    • DIALIPID, s.r.o.
  • Roznava, Slovakia, 04801
    • Recruiting
    • Tatratrial s.r.o.
  • Sturovo, Slovakia, 943 01
    • Recruiting
    • Ambulancia diabetologie a poruch latkovej premeny a vyzivy_Sturovo
• South Africa
  • Gauteng
    • Benoni, Gauteng, South Africa, 1501
      • Recruiting
      • Diabetes Care Centre & CDE Centre
    • Johannesburg, Gauteng, South Africa, 1501
      • Recruiting
      • East Rand Physicians
    • Johannesburg, Gauteng, South Africa, 2198
      • Not yet recruiting
      • Centre for Diabetes
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Recruiting
      • Dr J Reddy
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Not yet recruiting
      • Dr Pillay's Rooms
    • Umkomaas, KwaZulu-Natal, South Africa, 4170
      • Recruiting
      • Dr T Padayachee
• Spain
  • Almeria, Spain, 04009
    • Withdrawn
    • Centro Periférico de Especialidades Bola Azul
  • La Roca del Vallés, Spain, 08430
    • Recruiting
    • ABS La Roca del Vallés
  • Madrid, Spain, 28031
    • Recruiting
    • Hospital Infanta Leonor
  • Palma de Mallorca, Spain, 07120
    • Active, not recruiting
    • Hospital Son Espases
  • Sevilla, Spain, 41010
    • Recruiting
    • Hospital Infanta Luisa
• Ukraine
  • Kharkiv, Ukraine, 61058
    • Withdrawn
    • Сommunal non-profit enterprise Regional Clinical Hospital
  • Khmelnytskyi, Ukraine, 29000
    • Withdrawn
    • CNI "Khmelnytskyi regional hospital" of KRC
  • Ternopil, Ukraine, 46001
    • Withdrawn
    • Ternopil Central District Hospital
  • Zaporizhzhia, Ukraine, 69037
    • Withdrawn
    • Medical centre"Elitmedservis"LLC
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Withdrawn
      • Lenzmeier Fam Med CCT Research
  • California
    • Concord, California, United States, 94520
      • Withdrawn
      • John Muir Physician Network
    • Fresno, California, United States, 93720
      • Recruiting
      • Valley Research
    • Fullerton, California, United States, 92835
      • Withdrawn
      • St. Jos Heritage Hlthcr_Fllrtn
    • Huntington Park, California, United States, 90255
      • Not yet recruiting
      • Velocity Clin Res Hunt Park
    • La Mesa, California, United States, 91942
      • Recruiting
      • Velocity Clin Res San Diego
    • Lancaster, California, United States, 93534
      • Recruiting
      • First Valley Medical Group
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda Univ Hlth Cr Endo
    • Los Angeles, California, United States, 90017
      • Withdrawn
      • Downtown LA Res Ctr. Inc.
    • Los Angeles, California, United States, 90057
      • Recruiting
      • Velocity Clin Res Wstlke
    • Northridge, California, United States, 91325
      • Recruiting
      • Valley Clinical Trials, Inc.
    • San Diego, California, United States, 92120
      • Recruiting
      • Wetlin Research Associates, Inc.
    • West Hills, California, United States, 91304
      • Recruiting
      • San Fernando Valley Hlth Inst
  • Florida
    • Hollywood, Florida, United States, 33021
      • Not yet recruiting
      • Encore Medical Research LLC
    • Jacksonville, Florida, United States, 32216
      • Recruiting
      • Jacksonville Ctr for Clin Res
    • Jacksonville, Florida, United States, 32204
      • Recruiting
      • Northeast Res Inst. Inc.
    • Miami, Florida, United States, 33165
      • Not yet recruiting
      • New Horizon Research Center
    • Miami, Florida, United States, 33169
      • Recruiting
      • Elite Research Center
    • Miami, Florida, United States, 33175
      • Recruiting
      • Reyes Clinical Research, Inc
    • Miami, Florida, United States, 33183
      • Not yet recruiting
      • International Research Associates, LLC_Miami
    • New Port Richey, Florida, United States, 34652
      • Recruiting
      • Suncoast Clinical Research, Inc._New Port Richey
    • Ocala, Florida, United States, 34470
      • Recruiting
      • Renstar Medical Research
  • Georgia
    • Atlanta, Georgia, United States, 30329-4015
      • Withdrawn
      • CVS Store Number: 7689
    • Hinesville, Georgia, United States, 31313
      • Recruiting
      • Coastal Heritage Clinical Research
    • Roswell, Georgia, United States, 30076
      • Withdrawn
      • Endocrine Research Solutions
    • Savannah, Georgia, United States, 31405-6901
      • Withdrawn
      • CVS Store Number: 05520
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Recruiting
      • Cedar-Crosse Research Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Compass Point Research
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • Withdrawn
      • West Broadway Clinic
    • West Des Moines, Iowa, United States, 50265
      • Recruiting
      • Iowa Diab & Endo Res Center
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Recruiting
      • Cotton O'Neil Clin Research Ctr
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Withdrawn
      • The Research Group of Lexington LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Withdrawn
      • AMR New Orleans
    • Slidell, Louisiana, United States, 70461-4231
      • Recruiting
      • Endo & Diab Care Assoc
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Withdrawn
      • MedStar Hlth Res Institute
    • Rockville, Maryland, United States, 20852
      • Recruiting
      • Endo And Metab Cons
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Joslin Center For Diabetes
  • Michigan
    • Buckley, Michigan, United States, 49620
      • Recruiting
      • Northern Pines Hlth Ctr, PC
    • Flint, Michigan, United States, 48532
      • Withdrawn
      • Elite Research Center
    • Troy, Michigan, United States, 48098
      • Recruiting
      • Arcturus Healthcare, PLC
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • Withdrawn
      • StudyMetrix Research LLC
  • Montana
    • Butte, Montana, United States, 59701
      • Recruiting
      • Mercury Str Med Grp, PLLC
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Recruiting
      • Palm Research Center Inc-Vegas
  • New Hampshire
    • Nashua, New Hampshire, United States, 03063
      • Recruiting
      • Southern New Hampshire Diabete
  • New York
    • Albany, New York, United States, 12203
      • Recruiting
      • Albany Medical College - Endo
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Recruiting
      • Carteret Medical Group
    • Morehead City, North Carolina, United States, 28557
      • Recruiting
      • Lucas Research Inc.
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Not yet recruiting
      • Lillestol Research LLC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Not yet recruiting
      • Velocity Clin Res Cleveland
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Diab & Endo Assoc of Stark Co
    • Canton, Ohio, United States, 44718
      • Not yet recruiting
      • Diab & Endo Assoc of Stark Co
    • Maumee, Ohio, United States, 43537
      • Recruiting
      • Advanced Med Res Maumee
    • Toledo, Ohio, United States, 43614
      • Recruiting
      • University of Toledo_Toledo
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson Univ Di Rsrch Ctr
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Withdrawn
      • Chattanooga Medical Research, Llc
    • Kingsport, Tennessee, United States, 37660
      • Recruiting
      • Holston Medical Group
    • Knoxville, Tennessee, United States, 37938
      • Recruiting
      • Accellacare._TN
  • Texas
    • Amarillo, Texas, United States, 79106
      • Recruiting
      • Amarillo Med Spec LLP
    • Arlington, Texas, United States, 76012-4637
      • Recruiting
      • Arlington Family Res. Ctr Inc
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Velocity Clinical Res-Dallas
    • Dallas, Texas, United States, 75208
      • Recruiting
      • Thyroid Endocrinology & Diabetes PA
    • Fort Worth, Texas, United States, 76132
      • Recruiting
      • Diabetes and Thyroid Ctr of FW
    • San Antonio, Texas, United States, 78230
      • Withdrawn
      • VIP Trials
    • San Antonio, Texas, United States, 78220
      • Withdrawn
      • San Antonio Prem Int Med
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Diabetes Glandular Diseases Clinic
    • San Antonio, Texas, United States, 78240
      • Not yet recruiting
      • Diabetes Glandular Diseases Clinic
    • Shavano Park, Texas, United States, 78231
      • Recruiting
      • Consano Clinical Research, LLC
    • Shavano Park, Texas, United States, 78231
      • Not yet recruiting
      • Consano Clinical Research, LLC
    • Waco, Texas, United States, 76708
      • Withdrawn
      • Hillcrest Family Health Center
  • Utah
    • Saint George, Utah, United States, 84790
      • Recruiting
      • Chrysalis Clinical Research
    • Salt Lake City, Utah, United States, 84117
      • Recruiting
      • Olympus Family Medicine
  • Virginia
    • Chesapeake, Virginia, United States, 23321
      • Withdrawn
      • Virginia Endo Res, LLC
    • Reston, Virginia, United States, 20191-4327
      • Withdrawn
      • CVS Store Number: 01396
    • Richmond, Virginia, United States, 23230-3005
      • Withdrawn
      • CVS Store Number: 1537
    • Winchester, Virginia, United States, 22601
      • Withdrawn
      • Amherst Family Practice P.C.
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • WVU Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insuline glargine U100 (reduced) + semaglutide; Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).	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).
Active Comparator: Insuline glargine U100 (titrated); Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Non-inferiority of semaglutide s.c. as add-on to dose-reduced insulin glargine to that of titrated insulin glargine will be assessed based on the clinically acceptable margin of 0.3 percentage (%) for the mean treatment difference in HbA1c. Measured as percentage.	From baseline (week 0) to end of treatment (week 40)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Measured as kilogram	From baseline (week 0) to end of treatment (week 40)
Relative Change in Daily Insulin Dose	Measured as percentage	From baseline (week 0) to end of treatment (week 40)
Change in HbA1c	Superiority of semaglutide s.c. as add-on to dose-reduced insulin glargine versus titrated insulin glargine will be assessed. Measured as percentage.	From baseline (week 0) to end of treatment (week 40)
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)	The questionnaire has been designed to measure the change in the level of satisfaction with diabetes treatment regimens in participants with diabetes who have had a recent intervention. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. Measured as score on a scale.	At end of treatment (week 40)
Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No)	Measured as count of participants	At end of treatment (week 40)
Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No)	Measured as count of participants	At end of treatment (week 40)
Participants Achieving: HbA1c less than 7 Percentage (Yes/No)	Measured as count of participants	At end of treatment (week 40)
Number of Severe Hypoglycaemic Episodes (Level 3)	Measured as number of episodes	From baseline (week 0) to end of treatment (week 40)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre (mmol/L) [54 Milligrams Per Decilitre (mg/dL)] Confirmed by Blood Glucose Meter)	Measured as number of episodes	From baseline (week 0) to end of treatment (week 40)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) or Severe Hypoglycaemic Episodes (Level 3)	Measured as number of episodes	From baseline (week 0) to end of treatment (week 40)
Participants Achieving All of The Following Targets: HbA1c Reduced From Baseline by At Least 0.3 %; Insulin Dose Reduced From Baseline; No Hypoglycaemic Episodes; No Weight Gain	No hypoglycaemic episodes defined as less than 3.9 mmol/L [70 milligrams per decilitre (mg/dL)] confirmed by Blood Glucose meter. Outcome measure measured as count of participants.	At end of treatment (week 40)
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)	The questionnaire has been designed to measure satisfaction with diabetes treatment regimens in participants with diabetes. The questionnaire contains 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Measured as score on a scale.	From baseline (week 0) to end of treatment (week 40)
Change in Score of Short Form 36 Version 2 (SF-36 v2)	The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.	From baseline (week 0) to end of treatment (week 40)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): May 21, 2025
• Study Completion (Estimated): July 2, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Insulin Glargine; Semaglutide
• Other Study ID Numbers: NN9535-4801; U1111-1267-0312 (Other Identifier: World Health Organization (WHO)); 2021-004392-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No