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QWINT-2: A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05362058
Collaborator
(none)
912
Enrollment
129
Locations
2
Arms
24.2
Anticipated Duration (Months)
7.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect and safety of LY3209590 compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
912 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes
Actual Study Start Date :
Jun 3, 2022
Anticipated Primary Completion Date :
Apr 14, 2024
Anticipated Study Completion Date :
Jun 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3209590

Participants will receive LY3209590 subcutaneously (SC) once weekly.

Drug: LY3209590
Administered SC
Active Comparator: Insulin Degludec

Participants will receive insulin degludec SC once daily

Drug: Insulin Degludec
Administered SC

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 52]

    Change from Baseline in HbA1c of LY3209590 compared to insulin degludec for the treatment of type 2 diabetes (T2D) in adults.

Secondary Outcome Measures

  1. Change from Baseline in HbA1c [Baseline, Week 52]

    Change from Baseline in HbA1c of LY3209590 compared to insulin degludec for participants using glucagon-like peptide-1 (GLP-1) receptor agonists

  2. Change from Baseline in HbA1c [Baseline, Week 52]

    Change from Baseline in HbA1c of LY3209590 compared to insulin degludec for participants not using GLP-1 receptor agonists

  3. Time in Glucose Range [Week 48 to Week 52]

    Time in glucose range between 70 and 180 milligram/deciliter inclusive, collected during the continued glucose monitoring session prior to week 52.

  4. Change from Baseline in Fasting Glucose [Baseline, Week 52]

    Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG)

  5. Weekly Insulin Dose [Baseline, Week 52]

    The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary.

  6. Level 2 or Level 3 Nocturnal Hypoglycemia Events [Baseline to Week 52]

    The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase.

  7. Change from Baseline in Body Weight [Baseline, Week 52]

    Change from baseline in body weight

  8. Time in hypoglycemia range with glucose <54 mg/dL [Week 48 to Week 52]

    Time in hypoglycemia with glucose <54 mg/dL measurements collected during continuous glucose monitoring (CGM) sessions collected prior to Week 52

  9. Time in Hyperglycemia range with glucose >180 mg/dL [Week 48 to Week 52]

    Time in hypoglycemia with glucose >180 mg/dL measurements collected during CGM sessions collected prior to Week 52

  10. Change from Baseline in Treatment-Related IMPACT Measures-Diabetes (TRIM-D) [Baseline, Week 52]

    TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. Each of the 28 items is assessed on a 5-point scale, where higher scores indicate a better health state.

  11. Change from Baseline in Short Form-36 Version 2 Health Survey Acute Form (SF-36) [Baseline, Week 52]

    SF-36 v2 Health Survey Acute form is a participant self-administered measure designed to assess these 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each domain is scored individually. Scoring of each domain and both summary scores, physical and mental component scores, are norm based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10. Higher scores indicate better levels of function and/or better health.

  12. Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) [Baseline, Week 52]

    EQ-5D-5L assesses 5 dimensions of health mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The 5L version scores each dimension at 5 levels, no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems. Each domain score ranges between less than 0 to 1, where negative values are valued as worse than dead, 0 is a health state equivalent to death, and 1 represents perfect health.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Have diagnosis of T2D according to the World Health Organization Criteria

  • Have an HbA1c of 7.0% - 10% inclusive, at screening

  • Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study

Exclusion Criteria:

  • Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.

  • Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.

  • Have had severe hypoglycemia episodes within 6 months prior to screening.

  • Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.

  • Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening

  • acute myocardial infarction

  • cerebrovascular accident (stroke), or

  • coronary bypass surgery.

  • Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening

  • Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neighborhood Healthcare Institute of Health Escondido California United States 92025
2 Valley Research Fresno California United States 93720
3 NorCal Medical Research, Inc Greenbrae California United States 94904
4 Catalina Research Institute, LLC Montclair California United States 91763
5 Southern California Dermatology, Inc. Santa Ana California United States 92701
6 New West Physicians Clinical Research Golden Colorado United States 80401
7 New England Research Associates, LLC Bridgeport Connecticut United States 06606
8 East Coast Institute for Research, LLC Jacksonville Florida United States 32204
9 East Coast Institute for Research - Canton Canton Georgia United States 30114
10 SKY Clinical Research Network Group-Blake Union City Georgia United States 30291
11 Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Springfield Illinois United States 62711
12 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
13 Qualmedica Research Bowling Green Kentucky United States 42101
14 Qualmedica Research, LLC Owensboro Kentucky United States 42301
15 Qualmedica Research, LLC Owensboro Kentucky United States 42301
16 MedStar Health Research Institute (MedStar Physician Based Research Network) Hyattsville Maryland United States 20782
17 Endocrine and Metabolic Consultants Rockville Maryland United States 20852
18 Quinn Healthcare/SKYCRNG Ridgeland Mississippi United States 39157
19 Clinvest Research LLC Springfield Missouri United States 65807
20 Velocity Clinical Research, Syracuse East Syracuse New York United States 13057
21 Great Lakes Medical Research, LLC Westfield New York United States 14787
22 Monroe Biomedical Research Monroe North Carolina United States 28112
23 Lucas Research, Inc Morehead City North Carolina United States 28557
24 Intend Research, LLC Norman Oklahoma United States 73069
25 Jefferson Clinical Research Institute (JCRI) Philadelphia Pennsylvania United States 19114
26 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
27 Dallas Diabetes Research Center Dallas Texas United States 75230
28 Juno Research Houston Texas United States 77040
29 Biopharma Informatic, LLC Houston Texas United States 77043
30 Southern Endocrinology Associates Mesquite Texas United States 75149
31 North Hills Family Medicine/North Hills Medical Research North Richland Hills Texas United States 76180
32 Consano Clinical Research, LLC Shavano Park Texas United States 78231
33 Multicare Institute for Research and Innovation Spokane Washington United States 99202
34 CEDOES Vitória Espírito Santo Brazil 29055450
35 Cline Research Center Curitiba Paraná Brazil 80030-480
36 Centro de Pesquisa Sao Lucas Campinas São Paulo Brazil 13034-685
37 CPCLIN Sao Paulo São Paulo Brazil 01228-200
38 Hospital São Lucas Copacabana Rio de Janeiro Brazil 22061-080
39 CPQuali Pesquisa Clínica São Paulo Brazil 01228-000
40 CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil 04266-010
41 LMC Clinical Research Inc. (Calgary) Calgary Alberta Canada T2H 2G4
42 LMC Clinical Research Inc. (Brampton) Brampton Ontario Canada L6S 0C6
43 Aggarwal and Associates Limited Brampton Ontario Canada L6T 0G1
44 LMC Clinical Research Inc. (Ottawa) Ottawa Ontario Canada K2J 0V2
45 Bluewater Clinical Research Group Inc. Sarnia Ontario Canada N7T 4X3
46 LMC Etobicoke Toronto Ontario Canada M9R 4E1
47 Fadia El Boreky Medicine Waterloo Ontario Canada N2J 1C4
48 9109-0126 Quebec Inc. Montreal Quebec Canada H4N 2W2
49 Beijing Hospital Beijing Beijing China 100005
50 Beijing Pinggu District Hospital Beijing Beijing China 101200
51 Beijing Tsinghua Changgung Hospital Changping Beijing China 102202
52 Chongqing General Hospital Chongqing Chongqing China 400014
53 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510120
54 Cangzhou People's Hospital Cangzhou Hebei China 061600
55 Hebei Medical University - Harrison International Peace Hospital Hengshui Shi Hebei China 053000
56 The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
57 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Shi Henan China 471003
58 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
59 Xiangya Hospital Central South University Changsha Hunan China 410008
60 The Second Xiangya Hospital of Central South University Changsha Hunan China 410011
61 The First People's Hospital of Yueyang Yueyang Hunan China 414000
62 Changzhou No.2 People's Hospital Changzhou Jiangsu China 213000
63 Nanjing First Hospital Nanjing Shi Jiangsu China 210012
64 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
65 Nanjing Medical University - Nanjing Jiangning Hospital Nanjing Jiangsu China 211100
66 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
67 The Affiliated Jiangyin Hospital of Southeast University Medical College Wuxi Shi Jiangsu China 214400
68 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212000
69 The Third Hospital of Nanchang Nanchang Jiangxi China 330009
70 The First Hospital of Jilin University Changchun Jilin China 130021
71 Shengjing Hospital of China Medical University Shenyang Liaoning China 110004
72 The Fourth Affiliated Hospital of Harbin Medical University Harbin Nangang District China 150001
73 Jinan Central Hospital Jinan Shandong China 250013
74 Shanghai 9th People hospital Shanghai Shanghai China 200023
75 Shanghai Putuo District Center Hospital Shanghai Shanghai China 200062
76 West China Hospital of Sichuan University Cheng Du Sichuan China 610041
77 Chengdu Fifth People's Hospital Chengdu Sichuan China 611130
78 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
79 Tianjin Medical University Zhu Xianyi Memorial Hospital Tianjin Tianjin China
80 Zhejiang Hospital Hangzhou Zhejiang China 310013
81 Ningbo First Hospital Ningbo Zhejiang China 315010
82 Wuxi People's Hospital Wuxi China 214003
83 INTENDIA klinika s.r.o. Chrudim III Chrudim Czechia 537 01
84 MUDr. Alena Vachova Ceske Budejovice Jihočeský Czechia 37011
85 MUDr. Tomas Hrdina Opocno Královéhradecký Kraj Czechia 517 73
86 MUDr. Tomas Edelsberger Krnov Moravskosl Czechia 79401
87 Milan Kvapil s.r.o., Diabetologicka ambulance Praha Praha 4 Czechia 14900
88 Diacentrum Brandys n.L. s.r.o. Brandys nad Labem Praha-vých Czechia 25001
89 Diahelp s.r.o Pardubice Czechia 530 02
90 Praxis Sauter & Sauter & Vorbach Wangen Baden-Württemberg Germany 88239
91 InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen Germany 45136
92 Medizentrum Essen Borbeck Essen Nordrhein-Westfalen Germany 45355
93 Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz Ludwigshafen am Rhein Rheinland-Pfalz Germany 67059
94 Zentrum für klinische Studien Saint Ingbert Saarland Germany 66386
95 Universitaetsklinikum Carl Gustav Carus Dresden Dresden Sachsen Germany 01307
96 RED-Institut GmbH Oldenburg Schleswig-Holstein Germany 23758
97 Diabeteszentrum Hamburg West Hamburg Germany 22607
98 Iatriko Paleou Falirou Medical Center Paleo Faliro Attikí (Region) Greece 17562
99 Alexandra General Hospital of Athens Athens Attikí Greece 11528
100 Thermi Clinic Thessaloniki Thessaloníki Greece 570 01
101 Athens Euroclinic Athens Greece 115 21
102 Tosaki Clinic for Diabetes and Endocrinology Nagoya-shi Aichi Japan 468-0009
103 Kashiwa City Hospital Kashiwa Chiba Japan 277-0825
104 Tokuyama Clinic Mihama-ku,Chiba City Chiba Japan 261-0004
105 Nippon Kokan Fukuyama Hospital Fukuyama-shi Hiroshima Japan 721-0927
106 Hasegawa Medical Clinic Chitose Hokkaido Japan 066-0032
107 Manda Memorial Hospital Sapporo Hokkaido Japan 060-0062
108 MinamiAkatsukaClinic Mito Ibaraki Japan 311-4153
109 Nakakinen clinic Naka Ibaraki Japan 311-0113
110 Hayashi Diabetes Internal Medicine Clinic Chigasaki Kanagawa Japan 253-0044
111 Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Yamato-shi Kanagawa Japan 242-0004
112 Shimizu Clinic Fusa Saitama-shi Saitama Japan 336-0967
113 Oyama East Clinic Oyama Tochigi Japan 323-0022
114 Kumanomae Nishimura Clinic Arakawa-ku Tokyo Japan 116-0012
115 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
116 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
117 Hachioji Diabetes Clinic Hachioji Tokyo Japan 192-0083
118 Medical Corporation Sato Medical clinic Ootaku Tokyo Japan 143-0015
119 Tomonaga Clinic Shinjuku Tokyo Japan 160-0022
120 Yoshimura Clinic Kumamoto Japan 861-8039
121 Jinnouchi Hospital Kumamoto Japan 862-0976
122 Abe Clinic Oita Japan 870-0039
123 Kangwon National University Hospital Chuncheon-si Kang-won-do Korea, Republic of 24289
124 Hanyang University Guri Hospital Guri-si Kyǒnggi-do Korea, Republic of 11923
125 Severance Hospital, Yonsei University Health System Seoul Seoul-teuk Korea, Republic of 3722
126 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
127 Investigacion En Salud Y Metabolismo Sc Chihuahua Mexico 31217
128 Centro de Endocrinologia y Nutricion Caguas Puerto Rico 00725
129 Private Practice - Dr. Paola Mansilla-Letelier Guaynabo Puerto Rico 00970

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05362058
Other Study ID Numbers:
  • 18262
  • I8H-MC-BDCX
  • 2021-005891-21
First Posted:
May 5, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin

Study Results

No Results Posted as of Aug 18, 2022