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)
- Conditions
- Diabetes Mellitus, Type 2Obesity
- Interventions
- Registration Number
- NCT05514535
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 568
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insuline glargine U100 (titrated) 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). Insuline glargine U100 (reduced) + semaglutide Insuline glargine U100 (reduced) 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)). Insuline glargine U100 (reduced) + semaglutide 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)).
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 40) 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.
- Secondary Outcome Measures
Name Time Method Relative Change in Daily Insulin Dose From baseline (week 0) to end of treatment (week 40) Measured as percentage
Number of Severe Hypoglycaemic Episodes (Level 3) From baseline (week 0) to end of treatment (week 40) Measured as number of episodes
Change in Score of Short Form 36 Version 2 (SF-36 v2) From baseline (week 0) to end of treatment (week 40) 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.
Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No) At end of treatment (week 40) Measured as count of participants
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) From baseline (week 0) to end of treatment (week 40) Measured as number of episodes
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 At end of treatment (week 40) 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.
Change in Body Weight From baseline (week 0) to end of treatment (week 40) Measured as kilogram
Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No) At end of treatment (week 40) Measured as count of participants
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) From baseline (week 0) to end of treatment (week 40) Measured as number of episodes
Change in HbA1c From baseline (week 0) to end of treatment (week 40) Superiority of semaglutide s.c. as add-on to dose-reduced insulin glargine versus titrated insulin glargine will be assessed. Measured as percentage.
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) At end of treatment (week 40) 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.
Participants Achieving: HbA1c less than 7 Percentage (Yes/No) At end of treatment (week 40) Measured as count of participants
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs) From baseline (week 0) to end of treatment (week 40) 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.
Trial Locations
- Locations (106)
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
🇬🇷Thessaloniki, Greece
"Thermi" Private Hosital
🇬🇷Thessaloniki, Greece
Ospedale Santa Maria Goretti - UOD Diabetologia
🇮🇹Latina, LT, Italy
Ospedale Civile Campo di Marte
🇮🇹Lucca, LU, Italy
Istituto Scientifico San Raffaele
🇮🇹Milano, MI, Italy
Diabetes Care Centre & CDE Centre
🇿🇦Benoni, Gauteng, South Africa
East Rand Physicians
🇿🇦Johannesburg, Gauteng, South Africa
Centre for Diabetes
🇿🇦Johannesburg, Gauteng, South Africa
Dr J Reddy
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr Pillay's Rooms
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
🇿🇦Umkomaas, KwaZulu-Natal, South Africa
ABS La Roca del Vallés
🇪🇸La Roca del Vallés, Spain
Hospital Infanta Leonor
🇪🇸Madrid, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Infanta Luisa
🇪🇸Sevilla, Spain
DIALIPID, s.r.o.
🇸🇰Presov, Slovakia
Tatratrial s.r.o.
🇸🇰Roznava, Slovakia
BENROD s.r.o.
🇸🇰Sturovo, Slovakia
University Hospital of Athens ATTIKON
🇬🇷Athens, Attica, Greece
University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
"Laiko" General Hospital of Athens
🇬🇷Athens, Greece
Alexandra General Hospital, Therapeutic Clinic
🇬🇷Athens, Greece
General Hospital of Nikaia
🇬🇷Nikaia, Greece
AHEPA General University Hospital
🇬🇷Thessaloniki, Greece
Velocity Clin Res Los Angeles
🇺🇸Los Angeles, California, United States
Valley Research
🇺🇸Fresno, California, United States
First Valley Medical Group
🇺🇸Lancaster, California, United States
Loma Linda Univ Hlth Cr Endo
🇺🇸Loma Linda, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Wetlin Research Associates, Inc.
🇺🇸San Diego, California, United States
San Fernando Valley Hlth Inst
🇺🇸West Hills, California, 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
Elite Research Center
🇺🇸Miami, Florida, United States
Reyes Clinical Research, Inc
🇺🇸Miami, 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
Coastal Heritage Clinical Research
🇺🇸Hinesville, Georgia, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Iowa Diab & Endo Res Center
🇺🇸West Des Moines, Iowa, United States
Cotton O'Neil Clin Research Ctr
🇺🇸Topeka, Kansas, United States
Endo & Diab Care Assoc
🇺🇸Slidell, Louisiana, United States
Endo And Metab Cons
🇺🇸Rockville, Maryland, United States
Joslin Center For Diabetes
🇺🇸Boston, Massachusetts, United States
Northern Pines Hlth Ctr, PC
🇺🇸Buckley, Michigan, United States
Arcturus Healthcare, PLC
🇺🇸Troy, Michigan, United States
Mercury Str Med Grp, PLLC
🇺🇸Butte, Montana, United States
Palm Research Center Inc-Vegas
🇺🇸Las Vegas, Nevada, United States
Southern New Hampshire Diabete
🇺🇸Nashua, New Hampshire, United States
Albany Medical College - Endo
🇺🇸Albany, New York, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Lucas Research Inc.
🇺🇸Morehead City, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Diab & Endo Assoc of Stark Co
🇺🇸Canton, Ohio, United States
Advanced Med Res Maumee
🇺🇸Maumee, Ohio, United States
University of Toledo_Toledo
🇺🇸Toledo, Ohio, United States
Thomas Jefferson Univ Di Rsrch Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Accellacare._TN
🇺🇸Knoxville, Tennessee, United States
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Arlington Family Res. Ctr Inc
🇺🇸Arlington, Texas, United States
Thyroid Endocrinology & Diabetes PA
🇺🇸Dallas, Texas, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
Diabetes Glandular Diseases Clinic
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Olympus Family Medicine
🇺🇸Salt Lake City, Utah, United States
EDUMED s.r.o. Nachod
🇨🇿Náchod, Czechia
Diahelp - diabetologie
🇨🇿Pardubice 5, Czechia
MUDr. Jitka Zemanova diabetologie a interna
🇨🇿Plzen - Vychodni Predmesti, Czechia
Diabet2 s.r.o.
🇨🇿Praha 1, Czechia
MUDr. Michala Pelikanova
🇨🇿Praha 4, Czechia
ResTrial s.r.o.
🇨🇿Praha 8, Czechia
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
🇮🇹Perugia, Umbria, Italy
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Policlinico Mater Domini Università di Catanzaro
🇮🇹Catanzaro, Italy
ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
🇮🇹Montichiari, Italy
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Policlinico A. Gemelli
🇮🇹Rome, Italy
Unidade Local De Saude De Matosinhos E.P.E.
🇵🇹Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Unidade Local De Saude De Almada-Seixal E.P.E.
🇵🇹Almada, Portugal
Hospital de Braga
🇵🇹Braga, Portugal
Unidade Local De Saude Do Oeste E.P.E.
🇵🇹Caldas da Rainha, Portugal
Unidade Local De Saude Da Regiao De Leiria E.P.E.- Hospital de Santo André
🇵🇹Leiria, Portugal
Unidade Local de Saúde de São José EPE - Hospital Curry Cabral
🇵🇹Lisboa, Portugal
Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
🇵🇹Lisboa, Portugal
Unidade Local de Saúde do Alto Minho E.P.E. - Viana do Castelo
🇵🇹Viana do Castelo, Portugal
SC Grand Med SRL
🇷🇴Oradea, Bihor, Romania
Spitalul Judetean de Urgenta Targoviste
🇷🇴Targoviste, Dambovita, Romania
CMI Dr Pop Lavinia
🇷🇴Baia Mare, Maramures, Romania
Novus Medical Clinica SRL
🇷🇴Ploiesti, Prahova, Romania
Centrul Medical Sfantul Stefan
🇷🇴Timisoara, Timis, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
🇷🇴Brasov, Romania
Clinic of Diabetes Constanta
🇷🇴Constanta, Romania
SC Consultmed SRL
🇷🇴Iasi, Romania
Medical Practice SRL
🇷🇴Oradea, Romania
Clinica Korall S.R.L. Satu Mare
🇷🇴Satu-Mare, Romania
DIA - CLARUS s.r.o.
🇸🇰Bojnice, Slovakia
MediTask, s.r.o
🇸🇰Bratislava, Slovakia
MEDISPEKTRUM s.r.o.
🇸🇰Bratislava, Slovakia
Diabetologicka ambulancia DIA-MAX s.r.o.
🇸🇰Levice, Slovakia
IN-DIA s.r.o.
🇸🇰Lucenec, Slovakia
FUNKYSTUFF s.r.o
🇸🇰Nove Zamky, Slovakia
Diakom, spol. s r.o.
🇸🇰Poprad, Slovakia