Clinical trial NCT05514535: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (\<=) 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.

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 40)
Secondary outcomes:
measure: Change in Body Weight
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Relative Change in Daily Insulin Dose
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in HbA1c
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
timeFrame: At end of treatment (week 40)
measure: Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No)
timeFrame: At end of treatment (week 40)
measure: Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No)
timeFrame: At end of treatment (week 40)
measure: Participants Achieving: HbA1c less than 7 Percentage (Yes/No)
timeFrame: At end of treatment (week 40)
measure: Number of Severe Hypoglycaemic Episodes (Level 3)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: 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)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: 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)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: 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
timeFrame: At end of treatment (week 40)
measure: Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Score of Short Form 36 Version 2 (SF-36 v2)
timeFrame: From baseline (week 0) to end of treatment (week 40)
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: San Fernando Valley Hlth Inst, LLC
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda Univ Hlth Cr Endo
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Los Angeles
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: San Diego
country: United States
facility: Wetlin Research Associates, Inc.
state: California
city: Hollywood
country: United States
facility: Encore Medical Research LLC
state: Florida
city: Jacksonville
country: United States
facility: Northeast Res Inst. Inc.
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Res
state: Florida
city: Miami
country: United States
facility: Elite Research Center
state: Florida
city: Miami
country: United States
facility: Reyes Clinical Research, Inc
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clin Res Port Richey
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc._New Port Richey
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Hinesville
country: United States
facility: Coastal Heritage Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diab & Endo Res Center
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Diab & Endo Res Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diab & Endo Ctr
state: Kansas
city: Slidell
country: United States
facility: Ileana J. Tandron, MD APMC (a private medical office)
state: Louisiana
city: Rockville
country: United States
facility: Endo And Metab Cons
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Buckley
country: United States
facility: Northern Pines Hlth Ctr, PC
state: Michigan
city: Troy
country: United States
facility: Arcturus HC PLC Troy Med Res
state: Michigan
city: Butte
country: United States
facility: Mercury Str Med Grp, PLLC
state: Montana
city: Las Vegas
country: United States
facility: Palm Research Center Inc-Vegas
state: Nevada
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research Inc.
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Canton
country: United States
facility: Diab & Endo Assoc of Stark Co
state: Ohio
city: Maumee
country: United States
facility: Advanced Med Res Maumee
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo_Toledo
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare US Inc., d/b/a Accellacare of Knoxville
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Arlington
country: United States
facility: Arlington Family Res. Ctr Inc
state: Texas
city: Dallas
country: United States
facility: Thyroid Endocrinology & Diabetes PA
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: San Antonio
country: United States
facility: Diabetes Glandular Diseases Clinic
state: Texas
city: San Antonio
country: United States
facility: Diabetes Glandular Diseases Clinic
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Olympus Family Medicine
state: Utah
city: Náchod
country: Czechia
facility: EDUMED s.r.o. Nachod
city: Pardubice 5
country: Czechia
facility: Diahelp - diabetologie
city: Plzen - Vychodni Predmesti
country: Czechia
facility: MUDr. Jitka Zemanova diabetologie a interna
city: Praha 1
country: Czechia
facility: Diabet2 s.r.o.
city: Praha 4
country: Czechia
facility: MUDr. Michala Pelikanova
city: Praha 8
country: Czechia
facility: ResTrial s.r.o.
city: Athens
country: Greece
facility: University Hospital of Athens ATTIKON
state: Attica
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Alexandra General Hospital, Therapeutic Clinic
city: Athens
country: Greece
facility: Alexandra General Hospital, Therapeutic Clinic
city: Nikaia
country: Greece
facility: General Hospital of Nikaia
city: Thessaloniki
country: Greece
facility: AHEPA General University Hospital
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Napoli
country: Italy
facility: A.O.U. Università Studi della Campania "Luigi Vanvitelli"
state: Campania
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti - UOD Diabetologia
state: LT
city: Lucca
country: Italy
facility: Ospedale Civile Campo di Marte
state: LU
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele
state: MI
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
state: Umbria
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Catanzaro
country: Italy
facility: Policlinico Mater Domini Università di Catanzaro
city: Montichiari
country: Italy
facility: ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
city: Napoli
country: Italy
facility: A.O.U. Università Studi della Campania "Luigi Vanvitelli"
city: Rome
country: Italy
facility: Policlinico A. Gemelli
city: Senhora Da Hora, Matosinhos
country: Portugal
facility: Unidade Local De Saude De Matosinhos E.P.E.
state: Matosinhos
city: Almada
country: Portugal
facility: Unidade Local De Saude De Almada-Seixal E.P.E.
city: Braga
country: Portugal
facility: Hospital de Braga
city: Caldas da Rainha
country: Portugal
facility: Unidade Local De Saude Do Oeste E.P.E.
city: Leiria
country: Portugal
facility: Unidade Local De Saude Da Regiao De Leiria E.P.E.- Hospital de Santo André
city: Lisboa
country: Portugal
facility: Unidade Local de Saúde de São José EPE - Hospital Curry Cabral
city: Lisboa
country: Portugal
facility: Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
city: Viana do Castelo
country: Portugal
facility: Unidade Local de Saúde do Alto Minho E.P.E. - Viana do Castelo
city: Oradea
country: Romania
facility: SC Grand Med SRL
state: Bihor
city: Targoviste
country: Romania
facility: Spitalul Judetean de Urgenta Targoviste
state: Dambovita
city: Baia Mare
country: Romania
facility: CMI Dr Pop Lavinia
state: Maramures
city: Ploiesti
country: Romania
facility: Novus Medical Clinica SRL
state: Prahova
city: Timisoara
country: Romania
facility: Centrul Medical Sfantul Stefan
state: Timis
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
city: Constanta
country: Romania
facility: Clinic of Diabetes Constanta
city: Iasi
country: Romania
facility: SC Consultmed SRL
city: Oradea
country: Romania
facility: Medical Practice SRL
city: Satu-Mare
country: Romania
facility: Clinica Korall S.R.L. Satu Mare
city: Bojnice
country: Slovakia
facility: DIA - CLARUS s.r.o.
city: Bratislava
country: Slovakia
facility: MediTask, s.r.o
city: Bratislava
country: Slovakia
facility: MEDISPEKTRUM s.r.o.
city: Levice
country: Slovakia
facility: Diabetologicka ambulancia DIA-MAX s.r.o.
city: Lucenec
country: Slovakia
facility: IN-DIA s.r.o.
city: Nove Zamky
country: Slovakia
facility: FUNKYSTUFF s.r.o
city: Poprad
country: Slovakia
facility: Diakom, spol. s r.o.
city: Presov
country: Slovakia
facility: DIALIPID, s.r.o.
city: Roznava
country: Slovakia
facility: Tatratrial s.r.o.
city: Sturovo
country: Slovakia
facility: BENROD s.r.o.
city: Benoni
country: South Africa
facility: Diabetes Care Centre & CDE Centre
state: Gauteng
city: Johannesburg
country: South Africa
facility: East Rand Physicians
state: Gauteng
city: Johannesburg
country: South Africa
facility: Centre for Diabetes
state: Gauteng
city: Durban
country: South Africa
facility: Dr J Reddy
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr Pillay's Rooms
state: KwaZulu-Natal
city: Umkomaas
country: South Africa
facility: Dr T Padayachee
state: KwaZulu-Natal
city: La Roca del Vallés
country: Spain
facility: ABS La Roca del Vallés
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: