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A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05275400
Collaborator
(none)
939
Enrollment
130
Locations
2
Arms
26.2
Anticipated Duration (Months)
7.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
939 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
Actual Study Start Date :
Mar 8, 2022
Anticipated Primary Completion Date :
Apr 12, 2024
Anticipated Study Completion Date :
May 14, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3209590

Participants will be given LY3209590 subcutaneously (SC).

Drug: LY3209590
Administered SC
Active Comparator: Insulin Degludec

Participants with be given insulin degludec SC.

Drug: Insulin Degludec
Administered SC

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 26]

    Change from Baseline in HbA1c of LY3209590 compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin.

Secondary Outcome Measures

  1. Nocturnal Hypoglycemia Event Rate [Baseline to Week 78]

    The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase up to Week 78.

  2. Time in Range [Week 22 to Week 26]

    Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session.

  3. Change from Baseline in Fasting Glucose [Baseline, Week 26]

    Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG).

  4. Weekly Insulin dose [Week 26]

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

  5. Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate [Baseline to Week 78]

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

  6. Change from Baseline in Body Weight [Baseline, Week 78]

    Change from baseline in body weight

  7. Time in Hypoglycemia Range [Week 22 to Week 26]

    Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL measured during the CGM session.

  8. Time in Hyperglycemia Range [Week 22 to Week 26]

    Time in hyperglycemia range defined as time in hyperglycemia with glucose >180 mg/dL measured during the CGM session.

  9. Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) [Baseline, Week 26]

    TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment.

  10. Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) [Baseline, Week 26]

    DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.

  11. Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) [Baseline, Week 78]

    DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.

Eligibility Criteria

Criteria

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

  • Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin

  • Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening

  • Have HbA1c value of 6.5% - 10% inclusive, at screening

  • Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)

  • Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

  • once daily U100 or U200 of insulin degludec

  • once daily U100 or U300 of insulin glargine

  • once or twice daily U100 of insulin detemir, or

  • once or twice daily human insulin NPH

  • acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

  • dipeptidyl peptidase (DPP-4) IV inhibitors

  • SGLT2 inhibitors

  • metformin

  • alphaglucosidase inhibitors or,

  • Glucagon-Like Peptide-1 (GLP-1) receptor agonists

  • Participants must be willing to stay on stable dose throughout the study

Exclusion Criteria:

  • Have Type 1 diabetes mellitus

  • Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)

  • Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)

  • Have active or untreated malignancy

  • Are pregnant

  • Have a significant weight gain or loss the past 3 months

  • Have received anytime in the past 6 months, any of the following insulin therapies:

  • prandial insulin

  • insulin mixtures

  • inhaled insulin

  • U-500 insulin, or

  • continuous subcutaneous insulin infusion therapy

  • Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

  • acute myocardial infarctions

  • cerebrovascular accident (stroke), or

  • coronary bypass surgery

  • Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Investigations Little Rock Arkansas United States 72211
2 John Muir Physician Network Research Center Concord California United States 94520
3 AMCR Institute Escondido California United States 92025
4 Valley Research Fresno California United States 93720
5 Velocity Clinical Research, Huntington Park Huntington Park California United States 90255
6 Scripps Whittier Diabetes Institute La Jolla California United States 92037
7 Diabetes Associates Medical Group Orange California United States 92868
8 University Clinical Investigators, Inc. Tustin California United States 92780
9 Chase Medical Research, LLC Waterbury Connecticut United States 06708
10 Encore Medical Research Hollywood Florida United States 33021
11 New Horizon Research Center Miami Florida United States 33165
12 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
13 West Orange Endocrinology Ocoee Florida United States 34761
14 SKY Clinical Research Network Group - Cameron Lawrenceville Georgia United States 30044
15 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
16 American Health Network of Indiana, LLC - Avon Avon Indiana United States 46123
17 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
18 L-MARC Research Center Louisville Kentucky United States 40213
19 Endocrine and Metabolic Consultants Rockville Maryland United States 20852
20 Joslin Diabetes Center Boston Massachusetts United States 02215
21 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
22 HealthPartners Institute dba International Diabetes Center Minneapolis Minnesota United States 55416
23 SKY Clinical Research Network Group - Hall Fayette Mississippi United States 39069
24 Clinvest Research LLC Springfield Missouri United States 65807
25 Palm Research Center Tenaya Las Vegas Nevada United States 89128
26 Albany Medical College, Division of Community Endocrinology Albany New York United States 12203
27 NYC Research New York New York United States 10016
28 Lillestol Research Fargo North Dakota United States 58104
29 Aventiv Research Inc Columbus Ohio United States 43213
30 Intend Research, LLC Norman Oklahoma United States 73069
31 Heritage Valley Medical Group, Inc. Beaver Pennsylvania United States 15009
32 Jefferson Clinical Research Institute (JCRI) Philadelphia Pennsylvania United States 19114
33 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
34 Gadolin Research Beaumont Texas United States 77702
35 Dallas Diabetes Research Center Dallas Texas United States 75230
36 Juno Research Houston Texas United States 77040
37 Biopharma Informatic, LLC Houston Texas United States 77043
38 Southern Endocrinology Associates Mesquite Texas United States 75149
39 Texas Diabetes & Endocrinology, P.A. Round Rock Texas United States 78681
40 Consano Clinical Research, LLC Shavano Park Texas United States 78231
41 Rainier Clinical Research Center Renton Washington United States 98057
42 Consultorio de Investigación Clínica EMO SRL Ciudad Autonoma de Buenos Aire Buenos Aires Argentina C1405BUB
43 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina 1056
44 Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires Argentina 7600
45 Go Centro Medico San Nicolás San Nicolas Buenos Aires Argentina 2900
46 Stat Research S.A. Capital Federal Buenos Air Argentina 1023
47 Centro Médico Viamonte Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1120AAC
48 Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1128AAF
49 Instituto Centenario Caba Ciudad Autónoma De Buenos Aire Argentina 1204
50 Centro Medico Privado CEMAIC Capital Córdoba Argentina X5008HHW
51 CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Godoy Cruz Mendoza Argentina 5501
52 Instituto Médico Catamarca IMEC Rosario Santa Fe Argentina 2000
53 CEMEDIC Buenos Aires Argentina 1407
54 CENUDIAB Ciudad Autónoma de Buenos Aire Argentina C1440AAD
55 Centro Diabetológico Dr. Waitman Córdoba Argentina 5000
56 DRC Gyógyszervizsgáló Központ Balatonfüred Veszprém Hungary 8230
57 Kanizsai Dorottya Korhaz Nagykanizsa Zala Hungary 8800
58 Zala Megyei Szent Rafael Kórház Zalaegerszeg Zala Hungary 8900
59 Szent Margit Rendelintézet Budapest Hungary 1032
60 Szent János Kórház Budapest Hungary 1125
61 Strazsahegy Medicina Bt. Budapest Hungary H1171
62 Tokuyama Clinic Mihama-ku,Chiba City Chiba Japan 261-0004
63 Yuri Ono Clinic Sapporo Hokkaido Japan 060-0001
64 Nakamoto Internal Medicine Clinic Mito Ibaraki Japan 310-0826
65 Kozawa Eye Hospital and Diabetes Center Mito Ibaraki Japan 310-0845
66 Noritake Clinic Ushiku Ibaraki Japan 300-1207
67 Matoba Internal Medicine Clinic Ebina Kanagawa Japan 243-0432
68 Takai Internal Medicine Clinic Kamakura-shi Kanagawa Japan 247-0056
69 Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Yamato-shi Kanagawa Japan 242-0004
70 Shiraiwa Medical Clinic Kashiwara Osaka Japan 582-0005
71 Takatsuki Red Cross Hospital Takatsuki Osaka Japan 569-1045
72 Shimizu Clinic Fusa Saitama-shi Saitama Japan 336-0967
73 Oyama East Clinic Oyama Tochigi Japan 323-0022
74 The Institute of Medical Science, Asahi Life Foundation Chuo-ku Tokyo Japan 103-0002
75 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
76 Medical Corporation Chiseikai Tokyo Center Clinic Chuo-ku Tokyo Japan 103-0028
77 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
78 Jinnouchi Hospital Kumamoto Japan 862-0976
79 Heiwadai Hospital Miyazaki Japan 880-0034
80 Abe Clinic Oita Japan 870-0039
81 AMC Nishiumeda Clinic Osaka Japan 530-0001
82 Kangwon National University Hospital Chuncheon-si Kang-won-do Korea, Republic of 24289
83 Yonsei University-Wonju Severance Christian Hospital Wonju Kang-won-do Korea, Republic of 26426
84 Korea University Ansan Hospital Ansan-si Kyǒnggi-do Korea, Republic of 15355
85 Hanyang University Guri Hospital Guri-si Kyǒnggi-do Korea, Republic of 11923
86 Yeungnam Univeristy Medical Center Gyeongsan-si Kyǒngsangbuk-do Korea, Republic of 42415
87 Inje University Sanggye Paik Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 01757
88 Asan Medical Center Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 05505
89 Hallym University Kangnam Sacred Heart Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 07441
90 Kyung Hee University Hospital at Gangdong Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 134-090
91 Seoul National University Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 3080
92 Severance Hospital, Yonsei University Health System Seoul Seoul-teuk Korea, Republic of 3722
93 Ulsan University Hospital Ulsan Ulsan-Kwangyǒkshi Korea, Republic of 44033
94 CenterMed Lublin NZOZ Lublin Lubelskie Poland 20-044
95 Gabinety TERPA Lublin Lubelskie Poland 20-333
96 NZOZ Medica Lublin Lubelskie Poland 20-538
97 Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET Krakow Małopolskie Poland 31-261
98 Centrum Zdrowia Tuchów Wierzchosławice Małopolskie Poland 33-122
99 Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie Poland 80-546
100 OMEDICA Medical Center Poznan Wielkopolskie Poland 60-111
101 Gaja Poradnie Lekarskie Maciej Wiza Poznan Wielkopolskie Poland 61-251
102 Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz Łódzkie Poland
103 IRMED Osrodek Badan Klinicznych Piotrkow Trybunalski Łódzkie Poland 97-300
104 NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki Ruda Slaska Śląskie Poland 41-709
105 Private Practice Dr. Martha Gomez Cuellar San Juan Puerto Rico 00921
106 GCM Medical Group, PSC - Hato Rey Site San Juan Puerto Rico 917
107 MediVet s.r.o. Malacky Bratislavský Kraj Slovakia 901 01
108 Human Care s.r.o. Kosice Košický Kraj Slovakia 04 012
109 Areteus Trebisov Košický Kraj Slovakia 075 01
110 MEDI-DIA s.r.o. Sabinov Prešovský Kraj Slovakia 083 01
111 DIA-MED CENTRUM s.r.o. Puchov Trenčiansky Kraj Slovakia 020 01
112 Diacrin .s.ro. Bratislava Slovakia 84102
113 ENDIAMED s.r.o Dolny Kubin Žilinský Kraj Slovakia 026 01
114 Complejo Hospitalario Universitario A Coruña A Coruña A Coruña [La Coruña] Spain 15006
115 Centro Periférico de Especialidades Bola Azul Almeria Almería Spain 04009
116 Hospital Universitario Virgen de la Victoria Malaga Andalucía Spain 29010
117 Hospital Quiron Infanta Luisa Sevilla Andalucía Spain 41010
118 Clínica Juaneda Palma de Mallorca Balears [Baleares] Spain 07014
119 Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona] Spain 08035
120 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
121 Vithas Hospital Sevilla Seville Sevilla Spain 41950
122 Hospital Universitario de La Ribera Alzira Valenciana, Comunitat Spain 46600
123 Hospital General Universitario de Valencia Valencia Valenciana, Comunitat Spain 46014
124 Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) Sevilla Spain 41003
125 Chung Shan Medical University Hospital Taichung City Taichung Taiwan 402
126 Taichung Veterans General Hospital Taichung City Taichung Taiwan 40705
127 Chi Mei Medical Center Tainan City Tainan Taiwan 71004
128 Fu Jen Catholic University Hospital New Taipei Taiwan 24352
129 National Cheng-Kung Uni. Hosp. Tainan Taiwan 704
130 Taipei Veterans General Hospital Taipei Taiwan 11217

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:
NCT05275400
Other Study ID Numbers:
  • 18237
  • I8H-MC-BDCU
  • 2021-002569-16
First Posted:
Mar 11, 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