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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1267-0312 | Other Identifier | World Health Organization (WHO) | |
| 2021-004392-13 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insuline glargine U100 (reduced) + semaglutide | Experimental | 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 (titrated) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) [Noninferiority] | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shoals Primary Care | Sheffield | Alabama | 35660 | United States | ||
| Lenzmeier Fam Med CCT Research |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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A total of 573 participants were randomised in a 1:1 manner to receive either once weekly (OW) semaglutide subcutaneous (s.c.) 2.0 mg and insulin glargine U100 (100 units/mL).
The study was conducted at 140 sites that recruited participants in 9 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insuline Glargine U100 (Reduced) + Semaglutide | Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2024 | Mar 5, 2026 |
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| Insuline glargine U100 (reduced) | Drug | 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). |
|
| Insuline glargine U100 (titrated) | Drug | 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). |
|
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] | 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) | 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) | 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% | 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% | 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) | 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) | 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) | 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 | 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) | 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) | 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) |
| Glendale |
| Arizona |
| 85308 |
| United States |
| Synexus Clinical Research US, Inc./Desert Clinical Research, | Mesa | Arizona | 85213 | United States |
| OneLife Direct Care Inc. | Searcy | Arkansas | 72143 | United States |
| Unity Health-Searcy Medical Center | Searcy | Arkansas | 72143 | United States |
| San Fernando Valley Hlth Inst, LLC | Canoga Park | California | 91304 | United States |
| Velocity Clin Res-Chula Vista | Chula Vista | California | 91911 | United States |
| John Muir Physicians Network | Concord | California | 94520 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Ascada Research | Fullerton | California | 92835 | United States |
| Providence Medical Foundation | Fullerton | California | 92835 | United States |
| Velocity Clinical Research Huntington Park | Huntington Park | California | 90255 | United States |
| Scripps Memorial Hospital La Jolla | La Jolla | California | 92037 | United States |
| Velocity Clin Res San Diego | La Mesa | California | 91942 | United States |
| First Valley Medical Group | Lancaster | California | 93534 | United States |
| Loma Linda Univ Hlth Cr Endo | Loma Linda | California | 92354 | United States |
| Torrance Clin Res Inst, Inc. | Lomita | California | 90717 | United States |
| NRC Research Institute | Los Angeles | California | 90015 | United States |
| Downtown LA Res Ctr. Inc. | Los Angeles | California | 90017 | United States |
| Velocity Clin Res Los Angeles | Los Angeles | California | 90017 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| San Diego Family Care_San Diego | San Diego | California | 92111 | United States |
| Wetlin Research Associates, Inc. | San Diego | California | 92120 | United States |
| University Clin Investigators | Tustin | California | 92780 | United States |
| Velocity Clin Res, Denver | Denver | Colorado | 80209 | United States |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | United States |
| Indago Research & Health Center Inc. | Hialeah | Florida | 33012 | United States |
| Encore Medical Research LLC | Hollywood | Florida | 33024 | United States |
| Northeast Res Inst. Inc. | Jacksonville | Florida | 32204 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| Care-Partners-Clinical-Research, LLC | Jacksonville | Florida | 32277 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Elite Research Center | Miami | Florida | 33169 | United States |
| Diverse Clinical Research Miami | Miami | Florida | 33175 | United States |
| Reyes Clinical Research, Inc | Miami | Florida | 33175 | United States |
| International Research Associates, LLC_Miami | Miami | Florida | 33183 | United States |
| South Broward Research LLC | Miramar | Florida | 33027 | United States |
| Suncoast Clin Res Port Richey | New Port Richey | Florida | 34652 | United States |
| Suncoast Clinical Research, Inc._New Port Richey | New Port Richey | Florida | 34652 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Clinical Research Trials of Florida | Tampa | Florida | 33607 | United States |
| CVS Store Number: 7689 | Atlanta | Georgia | 30329-4015 | United States |
| East Coast Institute for Res | Canton | Georgia | 30114 | United States |
| Coastal Heritage Clinical Research | Hinesville | Georgia | 31313 | United States |
| East Coast Institute for Res | Macon | Georgia | 31210 | United States |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | United States |
| CVS Store Number: 05520 | Savannah | Georgia | 31405-6901 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| WellNow Urgent Care | Chicago | Illinois | 60661 | United States |
| Brengle Family Medicine | Indianapolis | Indiana | 46260 | United States |
| West Broadway Clinic | Council Bluffs | Iowa | 51501 | United States |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50265 | United States |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50266 | United States |
| Cotton O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | United States |
| The Research Group of Lexington LLC | Lexington | Kentucky | 40503 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Arthritis And Diabetes Clinic, Inc. | Monroe | Louisiana | 71203 | United States |
| AMR New Orleans | New Orleans | Louisiana | 70119 | United States |
| Ileana J. Tandron, MD APMC (a private medical office) | Slidell | Louisiana | 70461 | United States |
| MedStar Hlth Res Institute | Hyattsville | Maryland | 20782 | United States |
| Endo And Metab Cons | Rockville | Maryland | 20852 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Elite Research Center | Flint | Michigan | 48532 | United States |
| Arcturus HC PLC Troy Med Res | Troy | Michigan | 48098 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | United States |
| Mercury Str Med Grp, PLLC | Butte | Montana | 59701 | United States |
| Clinical Research Advantage, Inc./Skyline Medical Center, PC | Elkhorn | Nebraska | 68022 | United States |
| Methodist Physicians Clinic | Fremont | Nebraska | 68025 | United States |
| Velocity Clin Res, Norfolk | Norfolk | Nebraska | 68701 | United States |
| Midwest Regional Health Services | Omaha | Nebraska | 68144 | United States |
| Univ of Nebraska Medical CTR | Omaha | Nebraska | 68198-3020 | United States |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89128 | United States |
| Southern New Hampshire Diabetes and Endocrinology | Nashua | New Hampshire | 03060 | United States |
| Premier Research Inc. | Trenton | New Jersey | 08611 | United States |
| AMC Community Endocrinology | Albany | New York | 12203 | United States |
| Dr. Alexander Perkelvald | Brooklyn | New York | 11229 | United States |
| Mid Hudson Med Res-New Windsor | New Windsor | New York | 12553 | United States |
| Great Lakes Medical Research | Westfield | New York | 14787 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27514 | United States |
| Physicians East Endocrinology | Greenville | North Carolina | 27834 | United States |
| Carteret Medical Group | Morehead City | North Carolina | 28557 | United States |
| Centricity Rsrch MHCity Multi | Morehead City | North Carolina | 28557 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| Velocity Clin Res Cleveland | Beachwood | Ohio | 44122 | United States |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | United States |
| Velocity Clin Res_Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Albert J Weisbrot | Mason | Ohio | 45040 | United States |
| Advanced Med Res Maumee | Maumee | Ohio | 43537 | United States |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| University of Toledo_Toledo | Toledo | Ohio | 43614 | United States |
| Intend Research | Norman | Oklahoma | 73069 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73069 | United States |
| Velocity Clinical Res Medford | Medford | Oregon | 97504 | United States |
| Heritage Valley Multispeciality Group Inc | Beaver | Pennsylvania | 15009 | United States |
| Richard M Kastelic MD Assoc | Johnstown | Pennsylvania | 15905 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Preferred Primary Care Physicians, Inc. | Uniontown | Pennsylvania | 15401 | United States |
| Carolina Health Specialists | Myrtle Beach | South Carolina | 29572 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| Univ Diab & Endo Consultants | Chattanooga | Tennessee | 37411 | United States |
| Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Accellacare US Inc., d/b/a Accellacare of Knoxville | Knoxville | Tennessee | 37938 | United States |
| Clinical Neuroscience Solutions | Memphis | Tennessee | 38119 | United States |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | United States |
| Arlington Family Res. Ctr Inc | Arlington | Texas | 76012-4637 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Velocity Clin Res Austin | Cedar Park | Texas | 78613 | United States |
| Thyroid Endocrinology & Diabetes PA | Dallas | Texas | 75208 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| Academy of Diabetes, T&E | El Paso | Texas | 79935 | United States |
| Diabetes and Thyroid Ctr of FW | Fort Worth | Texas | 76132 | United States |
| Gonzalez Family & Occupational Medicine | Houston | Texas | 77029 | United States |
| JCCT- Juno NW Houston | Houston | Texas | 77040 | United States |
| Houston Institute for Clinical Research | Houston | Texas | 77074 | United States |
| Protenium Clinical Research | Hurst | Texas | 76054 | United States |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | United States |
| Tekton Research | McKinney | Texas | 75069 | United States |
| Clinical Investigations Of Texas | Plano | Texas | 75075 | United States |
| San Antonio Prem Int Med | San Antonio | Texas | 78220 | United States |
| Briggs Clinical Research, LLC | San Antonio | Texas | 78224 | United States |
| Diabetes Glandular Diseases Clinic | San Antonio | Texas | 78229 | United States |
| VIP Trials | San Antonio | Texas | 78230 | United States |
| Diabetes Glandular Diseases Clinic | San Antonio | Texas | 78240 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Med-Olam Clinical Reseach LLC | Sugar Land | Texas | 77479 | United States |
| Hillcrest Family Health Center | Waco | Texas | 76708 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| South Ogden Family Medicine/ CCT Research | Ogden | Utah | 84405 | United States |
| Olympus Family Medicine | Salt Lake City | Utah | 84117 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Velocity Clin Res-Salt Lk City | West Jordan | Utah | 84088 | United States |
| Virginia Endo Res, LLC | Chesapeake | Virginia | 23321 | United States |
| York Clinical Research LLC | Norfolk | Virginia | 23504 | United States |
| CVS Store Number: 01396 | Reston | Virginia | 20191-4327 | United States |
| CVS Store Number: 1537 | Richmond | Virginia | 23230-3005 | United States |
| Amherst Family Practice P.C. | Winchester | Virginia | 22601 | United States |
| WVU Medicine | Morgantown | West Virginia | 26506 | United States |
| Prevea Health | Green Bay | Wisconsin | 54303 | United States |
| EDUMED s.r.o. | Náchod | 547 01 | Czechia |
| Diahelp - diabetologie | Pardubice | 530 02 | Czechia |
| MUDr. Jitka Zemanova - diabetologie a interna, s.r.o. | Plzen - Vychodni Predmesti | 326 00 | Czechia |
| Diabet2 s.r.o. | Prague | 110 00 | Czechia |
| MUDr. Michala Pelikanova | Prague | 140 00 | Czechia |
| ResTrial s.r.o. | Prague | 18100 | Czechia |
| University Hospital of Athens ATTIKON | Athens | Attica | 12462 | Greece |
| University Hospital of Alexandroupolis | Alexandroupoli | 68100 | Greece |
| "Laiko" General Hospital of Athens | Athens | 11527 | Greece |
| Alexandra General Hospital, Therapeutic Clinic | Athens | 11528 | Greece |
| Alexandra General Hospital, Therapeutic Clinic | Athens | GR-11528 | Greece |
| Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department | Nikaia | GR-18454 | Greece |
| Geniko Nosokomeio Peiraia Tzaneio | Piraeus | 18536 | Greece |
| AHEPA General University Hospital | Thessaloniki | 54636 | Greece |
| EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes | Thessaloniki | 54645 | Greece |
| "Thermi" Private Hosital | Thessaloniki | 57001 | Greece |
| General Hospital of Thessaloniki "G.Papanikolaou" | Thessaloniki | 57010 | Greece |
| "Thermi" Private Hosital | Thessaloniki | GR-57001 | Greece |
| A.O.U. Università Studi della Campania "Luigi Vanvitelli" | Naples | Campania | 80138 | Italy |
| Ospedale Santa Maria Goretti - UOD Diabetologia | Latina | LT | 04100 | Italy |
| Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte | Lucca | LU | 55100 | Italy |
| Istituto Scientifico San Raffaele | Milan | MI | 20132 | Italy |
| Policlinico Umberto I Seconda Clinica Medica | Roma | RM | 00161 | Italy |
| Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia | Perugia | Umbria | 06129 | Italy |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Policlinico Mater Domini Università di Catanzaro | Catanzaro | 88100 | Italy |
| ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari | Montichiari | 25018 | Italy |
| A.O.U. Università Studi della Campania "Luigi Vanvitelli" | Naples | 80138 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche | Rome | 00168 | Italy |
| ULS De Matosinhos E.P.E.- Hospital Pedro Hispano | Senhora Da Hora, Matosinhos | Matosinhos | 4464-513 | Portugal |
| ULS De Almada-Seixal E.P.E. - Hospital Garcia de Orta | Almada | 2805-267 | Portugal |
| ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro | Aveiro | 3814-501 | Portugal |
| ULS De Braga, E.P.E. - Hospital de Braga | Braga | 4710-243 | Portugal |
| ULS Do Oeste E.P.E. - Unidade Caldas da Rainha | Caldas da Rainha | 2500-176 | Portugal |
| ULS Da Região De Leiria E.P.E.- Hospital de Santo André | Leiria | 2410-197 | Portugal |
| Unidade Local De Saúde De São José, E.P.E. - Hospital Curry Cabral | Lisbon | 1050-099 | Portugal |
| Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| ULS De Santo António, E.P.E. - Hospital de Santo António | Porto | 4099-001 | Portugal |
| ULS De São João, E.P.E. - Hospital de São João | Porto | 4200-319 | Portugal |
| ULS Do Alto Minho E.P.E. - Hospital de Santa Luzia | Viana do Castelo | 4904-858 | Portugal |
| Caribbean Medical Research Center | San Juan | 00918 | Puerto Rico |
| Medical Practice SRL | Oradea | Bihor County | 410001 | Romania |
| Grandmed SRL | Oradea | Bihor County | 410159 | Romania |
| Spitalul Judetean de Urgenta Targoviste | Targoviste | Dâmbovița County | 130083 | Romania |
| CMI Dr Pop Lavinia | Baia Mare | Maramureş | 430222 | Romania |
| Novus Medical Clinica SRL | Ploieşti | Prahova | 100018 | Romania |
| Centrul Medical Sfantul Stefan | Timișoara | Timiș County | 300125 | Romania |
| Mariodiab Clinic SRL | Brasov | 500101 | Romania |
| Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed | Brasov | 500283 | Romania |
| Clinica Grivitei 224 S.R.L. | Brăila | 810197 | Romania |
| Diabs&Nutricare Srl | Bucharest | 040172 | Romania |
| Clinic of Diabetes Constanta | Constanța | 900591 | Romania |
| Clinical Emergency Sf. Apostol Andrei Hospital | Galati | 800578 | Romania |
| SC Consultmed SRL | Iași | 700547 | Romania |
| S.C. Dianutrilife Medica S.R.L. | Ploieşti | 100561 | Romania |
| Clinica Korall S.R.L. Satu Mare | Satu Mare | 440055 | Romania |
| Dentosim Queen Srl | Târgu Mureş | 540098 | Romania |
| Volosevich First City Clinical Hospital | Arkhangelsk | 163001 | Russia |
| SPb SBHI "Snegirev Maternity Hospital No. 6" | Saint Petersburg | 191014 | Russia |
| Medinet LLC | Saint Petersburg | 194356 | Russia |
| SPb SBHI City polyclinic #117 | Saint Petersburg | 194358 | Russia |
| Medical Research Institute LLC | Saint Petersburg | 196084 | Russia |
| Solovyev Clinical Emergency Hospital | Yaroslavl | 150003 | Russia |
| Solovyov Clinical Emergency Hospital | Yaroslavl | 150003 | Russia |
| DIA - CLARUS s.r.o. | Bojnice | 97201 | Slovakia |
| MediTask, s.r.o | Bratislava | 83103 | Slovakia |
| MEDISPEKTRUM s.r.o. | Bratislava | 851 01 | Slovakia |
| DIA-MAX s.r.o. | Levice | 93401 | Slovakia |
| IN-DIA s.r.o. | Lučenec | 984 01 | Slovakia |
| DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy | Martin | 036 01 | Slovakia |
| FUNKYSTUFF s.r.o | Nové Zámky | 940 59 | Slovakia |
| Diakom, spol. s r.o. | Poprad | 05801 | Slovakia |
| DIALIPID, s.r.o. | Prešov | 080 01 | Slovakia |
| Tatratrial s.r.o. | Rožňava | 04801 | Slovakia |
| Amb. Diabetologie a prouch latkovej premeny a vyzivy ENDIANT s.r.o. | Sereď | 926 01 | Slovakia |
| BENROD s.r.o. | Štúrovo | 943 01 | Slovakia |
| MUDr. Korecova, metabolicke centrum s.r.o. | Trenčín | 911 01 | Slovakia |
| Diabetes Care Centre & CDE Centre | Benoni | Gauteng | 1501 | South Africa |
| East Rand Physicians | Benoni | Gauteng | 1501 | South Africa |
| East Rand Physicians | Johannesburg | Gauteng | 1501 | South Africa |
| Centre for Diabetes | Johannesburg | Gauteng | 2198 | South Africa |
| Dr J Reddy | Durban | KwaZulu-Natal | 4450 | South Africa |
| Dr Pillay's Rooms | Durban | KwaZulu-Natal | 4450 | South Africa |
| Dr T Padayachee | eMkhomazi | KwaZulu-Natal | 4170 | South Africa |
| Centro Periférico de Especialidades Bola Azul | Almería | 04009 | Spain |
| ABS La Roca del Vallés_Endocrinología | La Roca Del Vallés | 08430 | Spain |
| ABS La Roca del Vallés | La Roca Del Vallés | 08430 | Spain |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
| H. Infanta Luisa_Endocrino y Obesidad | Seville | 41010 | Spain |
| Kharkiv Regional Clinical Hospital - Endocrinology department | Kharkiv | 61058 | Ukraine |
| Khmelnytskyi Regional Hospital - Endocrinology department | Khmelnytskyi | 29000 | Ukraine |
| Ternopil Central District Hospital - Outpatient department | Ternopil | 46001 | Ukraine |
| Medical centre"Elitmedservis"LLC | Zaporizhzhia | 69037 | Ukraine |
| Insuline Glargine U100 (Titrated) |
Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks. |
| Safety Analysis Set (SAS) |
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| Full Analysis Set (FAS) |
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| COMPLETED |
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| NOT COMPLETED |
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FAS included all randomized participants and were analysed according to the planned intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insuline Glargine U100 (Reduced) + Semaglutide | Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks. |
| BG001 | Insuline Glargine U100 (Titrated) | Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Change in Glycated Haemoglobin (HbA1c) [Noninferiority] | 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. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage point of HbA1c | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | Change in Body Weight | Change in body weight from baseline (Week 0) to end of treatment (Week 40) were reported. Body weight was measured in unit 'Kilogram (kg)'. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Kilograms | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | Percentage Change in Daily Insulin Dose | 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. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of daily insulin dose | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | Change in Glycated Haemoglobin (HbA1c ) [Superiority] | Change in HbA1c (Superiority) from baseline (Week 0) to end of treatment (Week 40) were reported. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage-point of HbA1c | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) | 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. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | At end of treatment (week 40) |
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| Secondary | Number of Participants Achieving Insulin Dose = 0 Units/mL (U) | Number of participants achieving Insulin dose = 0 U at the end of treatment (Week 40) were reported. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | At end of treatment (week 40) |
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| Secondary | Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50% | Number of participants achieving Insulin dose reduced from baseline by at least 50% by end pf treatment (Week 40) were reported. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | At end of treatment (week 40) |
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| Secondary | Number of Participants Achieving HbA1c Less Than (<) 7% | Number of participants achieving HbA1c < 7% at the end of treatment (Week 40) were reported. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | At end of treatment (week 40) |
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| Secondary | Number of Severe Hypoglycaemic Episodes (Level 3) | 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. | SAS included all participants who were exposed to study intervention and analyzed according to the intervention they actually received. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | Episodes | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter) | 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. | SAS included all participants who were exposed to study intervention and analyzed according to the intervention they actually received. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | Episodes | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | 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) | 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. | SAS included all participants who were exposed to study intervention and analyzed according to the intervention they actually received. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | Episodes | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | 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 | 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. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | At end of treatment (week 40) |
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| Secondary | Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs) | 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. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on scale | From baseline (week 0) to end of treatment (week 40) |
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| Secondary | Change in Score of Short Form 36 Version 2 (SF-36 v2) | 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. | FAS included all randomized participants and were analysed according to the planned intervention. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | From baseline (week 0) to end of treatment (week 40) |
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From baseline (week 0) to the end of study (week 45)
AE is any medical occurrence (sign, symptom or disease) in a participant that is temporally associated with the use of an investigational medicinal product(IMP), whether or not related to the IMP. All AEs presented are treatment-emergent adverse events(TEAEs),that occur from the time of first dose of the trial intervention until the end of study. The SAS included all participants who were exposed to the study intervention and were analysed according to the intervention they received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | INSULIN GLARGINE (REDUCED) + SEMAGLUTIDE | Participants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks. | 1 | 288 | 17 | 288 | 92 | 288 |
| EG001 | INSULIN GLARGINE (TITRATED) | Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks. | 1 | 284 | 15 | 284 | 13 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Gallbladder disorder | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Incarcerated hernia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Meningitis viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Phimosis | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
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| Pilonidal disease | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Stress cardiomyopathy | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Subdiaphragmatic abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2025 | Mar 5, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks.
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| Participants |
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| OG001 | Insuline Glargine U100 (Titrated) | Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks. |
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