一项研究，旨在了解 Semaglutide 与较低剂量的甘精胰岛素相比，与单独使用较高剂量的甘精胰岛素相比，在 2 型糖尿病患者中的效果（SUSTAIN OPTIMIZE）
2026年4月17日 更新者：Novo Nordisk A/S
每周一次的 Semaglutide S.C. 2.0 mg 作为减量甘精胰岛素的附加药物与滴定甘精胰岛素在 2 型糖尿病和超重参与者中的疗效和安全性
这项研究在 2 型糖尿病参与者中比较了 semaglutide 和较低剂量的甘精胰岛素与较高剂量的甘精胰岛素。
该研究着眼于研究药物控制血糖水平的程度。
参与者将获得 semaglutide 以及较低剂量的甘精胰岛素或较高剂量的甘精胰岛素。
该研究将持续约 47 周（约 11 个月）。
参与者将进行 9 次门诊就诊、15 次电话/视频通话和 1 次家访。
参与者将被要求佩戴一个传感器，在研究期间的 10 天的 2 个时期内始终测量他们的血糖。
研究概览
研究类型
介入性
注册 (实际的)
573
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Kharkiv、乌克兰、61058
- Kharkiv Regional Clinical Hospital - Endocrinology department
-
Khmelnytskyi、乌克兰、29000
- Khmelnytskyi Regional Hospital - Endocrinology department
-
Ternopil、乌克兰、46001
- Ternopil Central District Hospital - Outpatient department
-
Zaporizhzhia、乌克兰、69037
- Medical centre"Elitmedservis"LLC
-
-
-
-
-
Arkhangelsk、俄罗斯、163001
- Volosevich First City Clinical Hospital
-
Saint Petersburg、俄罗斯、194356
- Medinet LLC
-
Saint Petersburg、俄罗斯、194358
- SPb SBHI City polyclinic #117
-
Saint Petersburg、俄罗斯、196084
- Medical Research Institute LLC
-
Saint Petersburg、俄罗斯、191014
- SPb SBHI "Snegirev Maternity Hospital No. 6"
-
Yaroslavl、俄罗斯、150003
- Solovyev Clinical Emergency Hospital
-
Yaroslavl、俄罗斯、150003
- Solovyov Clinical Emergency Hospital
-
-
-
-
Gauteng
-
Benoni、Gauteng、南非、1501
- Diabetes Care Centre & CDE Centre
-
Benoni、Gauteng、南非、1501
- East Rand Physicians
-
Johannesburg、Gauteng、南非、2198
- Centre for Diabetes
-
Johannesburg、Gauteng、南非、1501
- East Rand Physicians
-
-
KwaZulu-Natal
-
Durban、KwaZulu-Natal、南非、4450
- Dr Pillay's Rooms
-
Durban、KwaZulu-Natal、南非、4450
- Dr J Reddy
-
eMkhomazi、KwaZulu-Natal、南非、4170
- Dr T Padayachee
-
-
-
-
-
Alexandroupoli、希腊、68100
- University Hospital of Alexandroupolis
-
Athens、希腊、11527
- "Laiko" General Hospital of Athens
-
Athens、希腊、11528
- Alexandra General Hospital, Therapeutic Clinic
-
Athens、希腊、GR-11528
- Alexandra General Hospital, Therapeutic Clinic
-
Nikaia、希腊、GR-18454
- Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department
-
Piraeus、希腊、18536
- Geniko Nosokomeio Peiraia Tzaneio
-
Thessaloniki、希腊、GR-57001
- "Thermi" Private Hosital
-
Thessaloniki、希腊、54636
- AHEPA General University Hospital
-
Thessaloniki、希腊、57001
- "Thermi" Private Hosital
-
Thessaloniki、希腊、57010
- General Hospital of Thessaloniki "G.Papanikolaou"
-
Thessaloniki、希腊、54645
- EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
-
-
Attica
-
Athens、Attica、希腊、12462
- University Hospital of Athens ATTIKON
-
-
-
-
-
Bergamo、意大利、24127
- Azienda Ospedaliera Papa Giovanni XXIII
-
Catanzaro、意大利、88100
- Policlinico Mater Domini Università di Catanzaro
-
Montichiari、意大利、25018
- ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
-
Naples、意大利、80138
- A.O.U. Università Studi della Campania "Luigi Vanvitelli"
-
Rome、意大利、00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
-
-
Campania
-
Naples、Campania、意大利、80138
- A.O.U. Università Studi della Campania "Luigi Vanvitelli"
-
-
LT
-
Latina、LT、意大利、04100
- Ospedale Santa Maria Goretti - UOD Diabetologia
-
-
LU
-
Lucca、LU、意大利、55100
- Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
-
-
MI
-
Milan、MI、意大利、20132
- Istituto Scientifico San Raffaele
-
-
RM
-
Roma、RM、意大利、00161
- Policlinico Umberto I Seconda Clinica Medica
-
-
Umbria
-
Perugia、Umbria、意大利、06129
- Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
-
-
-
-
-
Náchod、捷克语、547 01
- Edumed s.r.o.
-
Pardubice、捷克语、530 02
- Diahelp - diabetologie
-
Plzen - Vychodni Predmesti、捷克语、326 00
- MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
-
Prague、捷克语、110 00
- Diabet2 s.r.o.
-
Prague、捷克语、140 00
- MUDr. Michala Pelikanova
-
Prague、捷克语、18100
- ResTrial s.r.o.
-
-
-
-
-
Bojnice、斯洛伐克、97201
- DIA - CLARUS s.r.o.
-
Bratislava、斯洛伐克、851 01
- MEDISPEKTRUM s.r.o.
-
Bratislava、斯洛伐克、83103
- MediTask, s.r.o
-
Levice、斯洛伐克、93401
- DIA-MAX s.r.o.
-
Lučenec、斯洛伐克、984 01
- IN-DIA s.r.o.
-
Martin、斯洛伐克、036 01
- DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
-
Nové Zámky、斯洛伐克、940 59
- FUNKYSTUFF s.r.o
-
Poprad、斯洛伐克、05801
- Diakom, spol. s r.o.
-
Prešov、斯洛伐克、080 01
- DIALIPID, s.r.o.
-
Rožňava、斯洛伐克、04801
- Tatratrial s.r.o.
-
Sereď、斯洛伐克、926 01
- Amb. Diabetologie a prouch latkovej premeny a vyzivy ENDIANT s.r.o.
-
Trenčín、斯洛伐克、911 01
- MUDr. Korecova, metabolicke centrum s.r.o.
-
Štúrovo、斯洛伐克、943 01
- BENROD s.r.o.
-
-
-
-
-
San Juan、波多黎各、00918
- Caribbean Medical Research Center
-
-
-
-
-
Brasov、罗马尼亚、500283
- Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
-
Brasov、罗马尼亚、500101
- Mariodiab Clinic SRL
-
Brăila、罗马尼亚、810197
- Clinica Grivitei 224 S.R.L.
-
Bucharest、罗马尼亚、040172
- Diabs&Nutricare Srl
-
Constanța、罗马尼亚、900591
- Clinic of Diabetes Constanta
-
Galati、罗马尼亚、800578
- Clinical Emergency Sf. Apostol Andrei Hospital
-
Iași、罗马尼亚、700547
- SC Consultmed SRL
-
Ploieşti、罗马尼亚、100561
- S.C. Dianutrilife Medica S.R.L.
-
Satu Mare、罗马尼亚、440055
- Clinica Korall S.R.L. Satu Mare
-
Târgu Mureş、罗马尼亚、540098
- Dentosim Queen Srl
-
-
Bihor County
-
Oradea、Bihor County、罗马尼亚、410159
- Grandmed SRL
-
Oradea、Bihor County、罗马尼亚、410001
- Medical Practice SRL
-
-
Dâmbovița County
-
Targoviste、Dâmbovița County、罗马尼亚、130083
- Spitalul Judetean de Urgenta Targoviste
-
-
Maramureş
-
Baia Mare、Maramureş、罗马尼亚、430222
- CMI Dr Pop Lavinia
-
-
Prahova
-
Ploieşti、Prahova、罗马尼亚、100018
- Novus Medical Clinica SRL
-
-
Timiș County
-
Timișoara、Timiș County、罗马尼亚、300125
- Centrul Medical Sfantul Stefan
-
-
-
-
Alabama
-
Sheffield、Alabama、美国、35660
- Shoals Primary Care
-
-
Arizona
-
Glendale、Arizona、美国、85308
- Lenzmeier Fam Med CCT Research
-
Mesa、Arizona、美国、85213
- Synexus Clinical Research US, Inc./Desert Clinical Research,
-
-
Arkansas
-
Searcy、Arkansas、美国、72143
- Unity Health-Searcy Medical Center
-
Searcy、Arkansas、美国、72143
- OneLife Direct Care Inc.
-
-
California
-
Canoga Park、California、美国、91304
- San Fernando Valley Hlth Inst, LLC
-
Chula Vista、California、美国、91911
- Velocity Clin Res-Chula Vista
-
Concord、California、美国、94520
- John Muir Physicians Network
-
Fresno、California、美国、93720
- Valley Research
-
Fullerton、California、美国、92835
- Providence Medical Foundation
-
Fullerton、California、美国、92835
- Ascada Research
-
Huntington Park、California、美国、90255
- Velocity Clinical Research Huntington Park
-
La Jolla、California、美国、92037
- Scripps Memorial Hospital La Jolla
-
La Mesa、California、美国、91942
- Velocity Clin Res San Diego
-
Lancaster、California、美国、93534
- First Valley Medical Group
-
Loma Linda、California、美国、92354
- Loma Linda Univ Hlth Cr Endo
-
Lomita、California、美国、90717
- Torrance Clin Res Inst, Inc.
-
Los Angeles、California、美国、90017
- Downtown LA Res Ctr. Inc.
-
Los Angeles、California、美国、90015
- NRC Research Institute
-
Los Angeles、California、美国、90017
- Velocity Clin Res Los Angeles
-
Northridge、California、美国、91325
- Valley Clinical Trials, Inc.
-
San Diego、California、美国、92120
- Wetlin Research Associates, Inc.
-
San Diego、California、美国、92111
- San Diego Family Care_San Diego
-
Tustin、California、美国、92780
- University Clin Investigators
-
-
Colorado
-
Denver、Colorado、美国、80209
- Velocity Clin Res, Denver
-
-
Connecticut
-
Waterbury、Connecticut、美国、06708
- Chase Medical Research LLC
-
-
Florida
-
Hialeah、Florida、美国、33012
- Indago Research & Health Center Inc.
-
Hollywood、Florida、美国、33024
- Encore Medical Research LLC
-
Jacksonville、Florida、美国、32216
- Jacksonville Ctr for Clin Res
-
Jacksonville、Florida、美国、32204
- Northeast Res Inst. Inc.
-
Jacksonville、Florida、美国、32277
- Care-Partners-Clinical-Research, LLC
-
Miami、Florida、美国、33165
- New Horizon Research Center
-
Miami、Florida、美国、33135
- Suncoast Research Group, LLC
-
Miami、Florida、美国、33175
- Reyes Clinical Research, Inc
-
Miami、Florida、美国、33183
- International Research Associates, LLC_Miami
-
Miami、Florida、美国、33169
- Elite Research Center
-
Miami、Florida、美国、33175
- Diverse Clinical Research Miami
-
Miramar、Florida、美国、33027
- South Broward Research LLC
-
New Port Richey、Florida、美国、34652
- Suncoast Clinical Research, Inc._New Port Richey
-
New Port Richey、Florida、美国、34652
- Suncoast Clin Res Port Richey
-
Ocala、Florida、美国、34470
- Renstar Medical Research
-
Tampa、Florida、美国、33607
- Clinical Research Trials of Florida
-
-
Georgia
-
Atlanta、Georgia、美国、30329-4015
- CVS Store Number: 7689
-
Canton、Georgia、美国、30114
- East Coast Institute for Res
-
Hinesville、Georgia、美国、31313
- Coastal Heritage Clinical Research
-
Macon、Georgia、美国、31210
- East Coast Institute for Res
-
Roswell、Georgia、美国、30076
- Endocrine Research Solutions
-
Savannah、Georgia、美国、31405-6901
- CVS Store Number: 05520
-
-
Idaho
-
Meridian、Idaho、美国、83646
- Solaris Clinical Research
-
-
Illinois
-
Chicago、Illinois、美国、60607
- Cedar-Crosse Research Center
-
Chicago、Illinois、美国、60661
- WellNow Urgent Care
-
-
Indiana
-
Indianapolis、Indiana、美国、46260
- Brengle Family Medicine
-
-
Iowa
-
Council Bluffs、Iowa、美国、51501
- West Broadway Clinic
-
West Des Moines、Iowa、美国、50265
- Iowa Diab & Endo Res Center
-
West Des Moines、Iowa、美国、50266
- Iowa Diab & Endo Res Center
-
-
Kansas
-
Topeka、Kansas、美国、66606
- Cotton O'Neil Diab & Endo Ctr
-
-
Kentucky
-
Lexington、Kentucky、美国、40503
- The Research Group of Lexington LLC
-
Louisville、Kentucky、美国、40213
- L-MARC Research Center
-
-
Louisiana
-
Monroe、Louisiana、美国、71203
- Arthritis and Diabetes Clinic, Inc.
-
New Orleans、Louisiana、美国、70119
- AMR New Orleans
-
Slidell、Louisiana、美国、70461
- Ileana J. Tandron, MD APMC (a private medical office)
-
-
Maryland
-
Hyattsville、Maryland、美国、20782
- MedStar Hlth Res Institute
-
Rockville、Maryland、美国、20852
- Endo And Metab Cons
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Joslin Diabetes Center
-
Boston、Massachusetts、美国、02115
- Brigham & Women's Hospital
-
-
Michigan
-
Buckley、Michigan、美国、49620
- Northern Pines Hlth Ctr, PC
-
Detroit、Michigan、美国、48202
- Henry Ford Health System
-
Flint、Michigan、美国、48532
- Elite Research Center
-
Troy、Michigan、美国、48098
- Arcturus HC PLC Troy Med Res
-
-
Missouri
-
City of Saint Peters、Missouri、美国、63303
- StudyMetrix Research LLC
-
-
Montana
-
Butte、Montana、美国、59701
- Mercury Str Med Grp, PLLC
-
-
Nebraska
-
Elkhorn、Nebraska、美国、68022
- Clinical Research Advantage, Inc./Skyline Medical Center, PC
-
Fremont、Nebraska、美国、68025
- Methodist Physicians Clinic
-
Norfolk、Nebraska、美国、68701
- Velocity Clin Res, Norfolk
-
Omaha、Nebraska、美国、68144
- Midwest Regional Health Services
-
Omaha、Nebraska、美国、68198-3020
- Univ of Nebraska Medical CTR
-
-
Nevada
-
Las Vegas、Nevada、美国、89128
- Palm Research Center Inc-Vegas
-
-
New Hampshire
-
Nashua、New Hampshire、美国、03060
- Southern New Hampshire Diabetes and Endocrinology
-
-
New Jersey
-
Trenton、New Jersey、美国、08611
- Premier Research Inc.
-
-
New York
-
Albany、New York、美国、12203
- AMC Community Endocrinology
-
Brooklyn、New York、美国、11229
- Dr. Alexander Perkelvald
-
New Windsor、New York、美国、12553
- Mid Hudson Med Res-New Windsor
-
Westfield、New York、美国、14787
- Great Lakes Medical Research
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27514
- University of North Carolina Medical Center
-
Greenville、North Carolina、美国、27834
- Physicians East Endocrinology
-
Morehead City、North Carolina、美国、28557
- Carteret Medical Group
-
Morehead City、North Carolina、美国、28557
- Centricity Rsrch MHCity Multi
-
-
North Dakota
-
Fargo、North Dakota、美国、58104
- Lillestol Research LLC
-
-
Ohio
-
Beachwood、Ohio、美国、44122
- Velocity Clin Res Cleveland
-
Canton、Ohio、美国、44718
- Diab & Endo Assoc of Stark Co
-
Cincinnati、Ohio、美国、45219
- Velocity Clin Res_Cincinnati
-
Mason、Ohio、美国、45040
- Albert J Weisbrot
-
Maumee、Ohio、美国、43537
- Advanced Med Res Maumee
-
Toledo、Ohio、美国、43614
- University of Toledo Medical Center
-
Toledo、Ohio、美国、43614
- University of Toledo_Toledo
-
-
Oklahoma
-
Norman、Oklahoma、美国、73069
- Lynn Institute of Norman
-
Norman、Oklahoma、美国、73069
- Intend Research
-
-
Oregon
-
Medford、Oregon、美国、97504
- Velocity Clinical Res Medford
-
-
Pennsylvania
-
Beaver、Pennsylvania、美国、15009
- Heritage Valley Multispeciality Group Inc
-
Johnstown、Pennsylvania、美国、15905
- Richard M Kastelic MD Assoc
-
Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University
-
Uniontown、Pennsylvania、美国、15401
- Preferred Primary Care Physicians, Inc.
-
-
South Carolina
-
Myrtle Beach、South Carolina、美国、29572
- Carolina Health Specialists
-
Summerville、South Carolina、美国、29485
- Palmetto Clinical Research
-
-
Tennessee
-
Chattanooga、Tennessee、美国、37404
- Chattanooga Medical Research, LLC
-
Chattanooga、Tennessee、美国、37411
- Univ Diab & Endo Consultants
-
Jackson、Tennessee、美国、38305
- Jackson Clinic
-
Kingsport、Tennessee、美国、37660
- Holston Medical Group
-
Knoxville、Tennessee、美国、37938
- Accellacare US Inc., d/b/a Accellacare of Knoxville
-
Memphis、Tennessee、美国、38119
- Clinical Neuroscience Solutions
-
-
Texas
-
Amarillo、Texas、美国、79106
- Amarillo Med Spec LLP
-
Arlington、Texas、美国、76012-4637
- Arlington Family Res. Ctr Inc
-
Austin、Texas、美国、78705
- Central Texas Clinical Research
-
Cedar Park、Texas、美国、78613
- Velocity Clin Res Austin
-
Dallas、Texas、美国、75230
- Velocity Clinical Res-Dallas
-
Dallas、Texas、美国、75208
- Thyroid Endocrinology & Diabetes PA
-
El Paso、Texas、美国、79935
- Academy of Diabetes, T&E
-
Fort Worth、Texas、美国、76132
- Diabetes and Thyroid Ctr of FW
-
Houston、Texas、美国、77074
- Houston Institute for Clinical Research
-
Houston、Texas、美国、77040
- JCCT- Juno NW Houston
-
Houston、Texas、美国、77029
- Gonzalez Family & Occupational Medicine
-
Hurst、Texas、美国、76054
- Protenium Clinical Research
-
Longview、Texas、美国、75605
- DCOL Ctr for Clin Res
-
McKinney、Texas、美国、75069
- Tekton Research
-
Plano、Texas、美国、75075
- Clinical Investigations of Texas
-
San Antonio、Texas、美国、78230
- VIP Trials
-
San Antonio、Texas、美国、78224
- Briggs Clinical Research, LLC
-
San Antonio、Texas、美国、78220
- San Antonio Prem Int Med
-
San Antonio、Texas、美国、78229
- Diabetes Glandular Diseases Clinic
-
San Antonio、Texas、美国、78240
- Diabetes Glandular Diseases Clinic
-
Shavano Park、Texas、美国、78231
- Consano Clinical Research, LLC
-
Sugar Land、Texas、美国、77479
- Med-Olam Clinical Reseach LLC
-
Waco、Texas、美国、76708
- Hillcrest Family Health Center
-
-
Utah
-
Ogden、Utah、美国、84405
- Advanced Research Institute
-
Ogden、Utah、美国、84405
- South Ogden Family Medicine/ CCT Research
-
Salt Lake City、Utah、美国、84117
- Olympus Family Medicine
-
St. George、Utah、美国、84790
- Chrysalis Clinical Research
-
West Jordan、Utah、美国、84088
- Velocity Clin Res-Salt Lk City
-
-
Virginia
-
Chesapeake、Virginia、美国、23321
- Virginia Endo Res, LLC
-
Norfolk、Virginia、美国、23504
- York Clinical Research LLC
-
Reston、Virginia、美国、20191-4327
- CVS Store Number: 01396
-
Richmond、Virginia、美国、23230-3005
- CVS Store Number: 1537
-
Winchester、Virginia、美国、22601
- Amherst Family Practice P.C.
-
-
West Virginia
-
Morgantown、West Virginia、美国、26506
- WVU Medicine
-
-
Wisconsin
-
Green Bay、Wisconsin、美国、54303
- Prevea Health
-
-
-
-
-
Almada、葡萄牙、2805-267
- ULS De Almada-Seixal E.P.E. - Hospital Garcia de Orta
-
Aveiro、葡萄牙、3814-501
- ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro
-
Braga、葡萄牙、4710-243
- ULS De Braga, E.P.E. - Hospital de Braga
-
Caldas da Rainha、葡萄牙、2500-176
- ULS Do Oeste E.P.E. - Unidade Caldas da Rainha
-
Leiria、葡萄牙、2410-197
- ULS Da Região De Leiria E.P.E.- Hospital de Santo André
-
Lisbon、葡萄牙、1349-019
- Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
-
Lisbon、葡萄牙、1050-099
- Unidade Local De Saúde De São José, E.P.E. - Hospital Curry Cabral
-
Porto、葡萄牙、4200-319
- ULS De São João, E.P.E. - Hospital de São João
-
Porto、葡萄牙、4099-001
- ULS De Santo António, E.P.E. - Hospital de Santo António
-
Viana do Castelo、葡萄牙、4904-858
- ULS Do Alto Minho E.P.E. - Hospital de Santa Luzia
-
-
Matosinhos
-
Senhora Da Hora, Matosinhos、Matosinhos、葡萄牙、4464-513
- ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
-
-
-
-
-
Almería、西班牙、04009
- Centro Periferico de Especialidades Bola Azul
-
La Roca Del Vallés、西班牙、08430
- ABS La Roca del Vallés
-
La Roca Del Vallés、西班牙、08430
- ABS La Roca del Vallés_Endocrinología
-
Madrid、西班牙、28031
- Hospital Infanta Leonor
-
Palma de Mallorca、西班牙、07120
- Hospital Son Espases
-
Seville、西班牙、41010
- H. Infanta Luisa_Endocrino y Obesidad
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 在筛选前大于或等于 (>=) 180 天被诊断患有 2 型糖尿病 (T2D)。
- 中心实验室在筛选当天评估的糖化血红蛋白 (HbA1c) 为 7-9% [(53-75 毫摩尔每摩尔 (mmol/mol)]（包括两者）。
- 筛选当天体重指数 (BMI) 大于或等于 (>=) 25 千克每平方米 (kg/m^2)。
- 在筛选以下任何抗糖尿病药物或联合治疗方案前 90 天稳定日剂量大于或等于 (>=)：
- 任何大于或等于 (>=) 1500 毫克 (mg) 或最大耐受剂量或有效剂量的二甲双胍制剂。
- 大于或等于 (>=) 1500 mg 或最大耐受剂量或有效剂量的任何二甲双胍组合制剂。
治疗可以使用或不使用钠葡萄糖协同转运蛋白 2 (SGLT-2) 抑制剂。
• 每日一次甘精胰岛素100 单位注射治疗小于或等于(<=) 40 单位/天大于或等于(>=) 筛选前90 天。 允许在筛选前进行最多 14 天的短期推注胰岛素治疗。
排除标准：
- 不受控制且可能不稳定的糖尿病性视网膜病变或黄斑病变。 通过在筛选前 90 天内或筛选和随机化之间的期间内进行的眼底检查进行验证。 药理学散瞳是一项要求，除非使用指定用于非散瞳检查的数字眼底摄影相机。
- 1 型糖尿病 (T1D) 或成人隐匿性自身免疫性糖尿病 (LADA) 的潜在漏诊，由 C 肽低于 0.5 纳摩尔/升 (nmol/L) [1.5 纳克/毫升 (ng/mL)] 或谷氨酸抗体证实酸性脱羧酶（抗 GAD）大于 5 单位/毫升，由中心实验室在筛选时测量。
- 胰腺炎（急性或慢性）的存在或病史。
- 根据肾脏疾病：改善全球预后 (KDIGO) 2012 分类的定义，肾功能不全的衡量标准是筛选时肾小球滤过率 (eGFR) 的估计值低于每 1.73 平方米每分钟 30 毫升。
- 筛查前 90 天内有任何糖尿病酮症酸中毒发作。
- 研究者根据 Clarke 的问卷问题 8 指出的已知的低血糖无意识。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：甘精胰岛素 U100（还原）+ semaglutide
参与者最初将皮下注射 0.25 毫克 (mg)，每周一次 semaglutide，剂量将逐渐增加至 2 mg，作为剂量减少的甘精胰岛素皮下注射的补充。
每天一次。
甘精胰岛素 U100 将在 semaglutide 开始时降低 10 U，然后在每次 semaglutide 剂量递增时再次降低。
甘精胰岛素剂量将根据三个早餐前自测血浆葡萄糖 (SMPG) 值的平均值进行调整（目标 SMPG：4.4-7.2
毫摩尔每升 (mmol/L)）。
|
参与者将接受每周一次的 semaglutide s.c. 40 周。
Semaglutide 0.25 mg 将在第 0 周给予，然后剂量将在第 4、8 和 12 周分别增加至 0.5 mg、1 mg、2 mg。
参与者将接受甘精胰岛素 U100 皮下注射。
每天一次。
甘精胰岛素剂量将在 semaglutide 开始时减少 10 U，然后在每次 semaglutide 剂量递增时再次减少，直至 40 周。
剂量将根据三个早餐前 SMPG 值的平均值进行调整（目标 SMPG：4.4-7.2
毫摩尔/升）。
|
|
有源比较器：甘精胰岛素 U100（滴定）
参与者将接受滴定的甘精胰岛素 U100 s.c.
每天一次。
甘精胰岛素 U100 剂量将根据三个早餐前 SMPG 值的平均值进行调整（目标 SMPG：4.4-7.2
毫摩尔/升）。
|
参与者将接受滴定的甘精胰岛素 U100 皮下注射。
每天一次，最多 40 周。
剂量将根据三个早餐前 SMPG 值的平均值进行调整（目标 SMPG：4.4-7.2
毫摩尔/升）。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c) [Noninferiority]
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Change in HbA1c (Noninferiority) from baseline (Week 0) to end of treatment (Week 40) were reported.
Here noninferiority was assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.
|
From baseline (week 0) to end of treatment (week 40)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Body Weight
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Change in body weight from baseline (Week 0) to end of treatment (Week 40) were reported.
Body weight was measured in unit 'Kilogram (kg)'.
|
From baseline (week 0) to end of treatment (week 40)
|
|
Percentage Change in Daily Insulin Dose
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Percentage change in daily insulin dose from baseline (Week 0) to end of treatment (Week 40) were reported.
Percentage change from baseline to week 40 in insulin dose (%) was calculated as: ([insulin dose at week 40] - [insulin dose at baseline]) / [insulin dose at baseline] × 100.
|
From baseline (week 0) to end of treatment (week 40)
|
|
Change in Glycated Haemoglobin (HbA1c ) [Superiority]
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Change in HbA1c (Superiority) from baseline (Week 0) to end of treatment (Week 40) were reported.
|
From baseline (week 0) to end of treatment (week 40)
|
|
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
大体时间：At end of treatment (week 40)
|
Score of Diabetes Treatment Satisfaction Questionnaire - change version (DTSQc) at end of treatment (week 40) were reported.
The DTSQc provided a measure of how satisfied participants were with their current diabetes treatment compared with previous treatment.
It consisted of 8 questions, which were 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.
Out of 8 questions, 6 questions related to treatment satisfaction were summed to produce a total score.
The DTSQc total treatment satisfaction score ranged from -18 to +18, with higher scores associated with greater treatment satisfaction.
|
At end of treatment (week 40)
|
|
Number of Participants Achieving Insulin Dose = 0 Units/mL (U)
大体时间：At end of treatment (week 40)
|
Number of participants achieving Insulin dose = 0 U at the end of treatment (Week 40) were reported.
|
At end of treatment (week 40)
|
|
Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50%
大体时间：At end of treatment (week 40)
|
Number of participants achieving Insulin dose reduced from baseline by at least 50% by end pf treatment (Week 40) were reported.
|
At end of treatment (week 40)
|
|
Number of Participants Achieving HbA1c Less Than (<) 7%
大体时间：At end of treatment (week 40)
|
Number of participants achieving HbA1c < 7% at the end of treatment (Week 40) were reported.
|
At end of treatment (week 40)
|
|
Number of Severe Hypoglycaemic Episodes (Level 3)
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported.
Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
|
From baseline (week 0) to end of treatment (week 40)
|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of treatment (week 40) were reported.
Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
|
From baseline (week 0) to end of treatment (week 40)
|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported.
Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
|
From baseline (week 0) to end of treatment (week 40)
|
|
Number of Participants Achieving HbA1c Reduced From Baseline by at Least 0.3%-Points and Insulin Dose Reduced From Baseline, No Hypoglycaemic Episodes (< 3.9 mmol/L (70 mg/dL) Confirmed by BG Meter) and No Weight Gain
大体时间：At end of treatment (week 40)
|
Number of Participants achieving HbA1c reduced from baseline by at least 0.3%-points and Insulin dose reduced from baseline, No hypoglycaemic episodes (< 3.9 mmol/L (70 mg/dL) confirmed by BG meter) and No weight gain at the end of treatment (Week 40) were reported.
|
At end of treatment (week 40)
|
|
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Score of Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) at end of treatment (week 40) were reported.
The status version measures a patient's current satisfaction with treatment using a 0-6 scale for each item; higher scores indicate greater satisfaction with the present treatment (absolute/status level).
The DTSQs total treatment satisfaction score ranged from 0 to 36, with higher scores associated with greater treatment satisfaction.
|
From baseline (week 0) to end of treatment (week 40)
|
|
Change in Score of Short Form 36 Version 2 (SF-36 v2)
大体时间：From baseline (week 0) to end of treatment (week 40)
|
Change in SF-36 physical and mental component from baseline (week 0) to end of treatment (Week 40) were presented.
SF-36 is self-administered questionnaire that measures each of following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception.
There are also 2 component scores derived from the 8 subscale scores: mental component summary and physical component summary.
Physical component summary contains physical functioning, role-physical, bodily pain and general health and mental component summary contain vitality, social functioning, role-emotional and mental health.
Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.
A positive change score indicates an improvement since baseline.
|
From baseline (week 0) to end of treatment (week 40)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Clinical Transparency (dept. 2834)、Novo Nordisk A/S
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年8月29日
初级完成 (实际的)
2025年3月5日
研究完成 (实际的)
2025年4月9日
研究注册日期
首次提交
2022年8月22日
首先提交符合 QC 标准的
2022年8月22日
首次发布 (实际的)
2022年8月24日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年4月17日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NN9535-4801
- U1111-1267-0312 (其他标识符：World Health Organization (WHO))
- 2021-004392-13 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
根据诺和诺德在novonordisk-trials.com上的披露承诺
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.