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QWINT-5: A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05463744
Collaborator
(none)
670
Enrollment
87
Locations
2
Arms
20
Anticipated Duration (Months)
7.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to measure the safety and efficacy of LY3209590 compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
670 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 Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Anticipated Study Start Date :
Aug 19, 2022
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Apr 19, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3209590

Participants will receive LY3209590 by subcutaneously (SC)

Drug: LY3209590
Administered SC
Active Comparator: Insulin Degludec

Participants will receive insulin degludec SC

Drug: Insulin Degludec
Administered SC

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Time in Glucose Range [Week 22 to Week 26]

    Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) [3.9 and 10.0 millimole/liter (mmol/L)] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26

  2. Nocturnal Hypoglycemia Event Rate [Baseline to Week 52]

    The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) measured during treatment phase up to week 52.

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

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

  4. Glucose Variability [Week 22 to Week 26]

    Glucose variability measured by CGM 4 weeks prior to week 26

  5. Basal Insulin Dose [Week 26]

  6. Bolus Insulin Dose [Week 26]

  7. Total Insulin Dose [Week 26]

  8. Rate of Composite Level 2 and 3 Hypoglycemia Events [Baseline to Week 52]

  9. Change from Baseline in Body Weight [Baseline, Week 26]

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

    Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL, measured by CGM 4 weeks prior to week 26.

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

    Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26.

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

    DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.

  13. Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores [Baseline, Week 26]

    SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.

Eligibility Criteria

Criteria

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

  • Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening

  • Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening

  • Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.

  • Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion Criteria:

  • Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes

  • Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 John Muir Physician Network Research Center Concord California United States 94520
2 Valley Research Fresno California United States 93720
3 Catalina Research Institute, LLC Montclair California United States 91763
4 Sansum Diabetes Research Institute Santa Barbara California United States 93105
5 University Clinical Investigators, Inc. Tustin California United States 92780
6 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045
7 Northeast Research Institute (NERI) Fleming Island Florida United States 32003
8 Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care Fort Lauderdale Florida United States 33312
9 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
10 Hanson Clinical Research Center Port Charlotte Florida United States 33952
11 East Coast Institute for Research, LLC Macon Georgia United States 31210
12 East-West Medical Research Institute Honolulu Hawaii United States 96814
13 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
14 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
15 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
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 Clinvest Research LLC Springfield Missouri United States 65807
19 Palm Research Center Tenaya Las Vegas Nevada United States 89128
20 Palm Research Center Sunset Las Vegas Nevada United States 89148
21 Research Foundation of SUNY - University of Buffalo Buffalo New York United States 14221
22 NYU Langone Hospital - Long Island Mineola New York United States 11501
23 NYC Research New York New York United States 10016
24 SUNY Upstate Medical University Syracuse New York United States 13210
25 Thomas Jefferson University - Clinical Research Institute Philadelphia Pennsylvania United States 19107
26 Texas Diabetes & Endocrinology, P.A. Austin Texas United States 78731
27 Dallas Diabetes Research Center Dallas Texas United States 75230
28 North Texas Endocrine Center Dallas Texas United States 75231
29 Research Institute of Dallas Dallas Texas United States 75231
30 Biopharma Informatic, LLC Houston Texas United States 77043
31 Private Practice - Dr. Amir Hassan Houston Texas United States 77089
32 Southern Endocrinology Associates Mesquite Texas United States 75149
33 Texas Diabetes & Endocrinology, P.A. Round Rock Texas United States 78681
34 Rainier Clinical Research Center Renton Washington United States 98057
35 CEDIC Caba Buenos Aires Argentina C1060ABN
36 Consultorio de Investigación Clínica EMO SRL Ciudad Autonoma de Buenos Aire Buenos Aires Argentina C1405BUB
37 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina 1056
38 CIAD Moron Moron Buenos Aires Argentina B1708EPE
39 Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1128AAF
40 Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1179AAB
41 Centro Medico Privado CEMAIC Capital Córdoba Argentina X5008HHW
42 Centro Diabetológico Dr. Waitman Cordoba Córdoba Argentina 5000
43 Centro Medico Privado San Vicente Diabetes Cordoba Córdoba Argentina 5006
44 Centro de Salud e Investigaciones Médicas Santa Rosa La Pampa Argentina 6300
45 CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Godoy Cruz Mendoza Argentina 5501
46 Centro de Investigaciones Médicas Tucuman SAN M. DE Tucuman Tucumán Argentina T4000AXL
47 Clínica Mayo San Miguel de Tucuman Tucumán Argentina 4000
48 Instituto Médico Especializado (IME) Buenos Aires Argentina 1405
49 Nirmal Hospital Pvt Ltd. Surat Gujarat India 395002
50 Victoria Hospital, Bangalore Medical College And Research Institute Bangalore Karnataka India 560002
51 Kumudini Devi Diabetes Research Center Hyderabad Telangana India 500072
52 Tosaki Clinic for Diabetes and Endocrinology Nagoya-shi Aichi Japan 468-0009
53 Yuri Ono Clinic Sapporo Hokkaido Japan 060-0001
54 Manda Memorial Hospital Sapporo Hokkaido Japan 060-0062
55 MinamiAkatsukaClinic Mito Ibaraki Japan 311-4153
56 Nakakinen clinic Naka Ibaraki Japan 311-0113
57 Noritake Clinic Ushiku Ibaraki Japan 300-1207
58 Takai Internal Medicine Clinic Kamakura-shi Kanagawa Japan 247-0056
59 Takatsuki Red Cross Hospital Takatsuki Osaka Japan 569-1045
60 Shimizu Clinic Fusa Saitama-shi Saitama Japan 336-0967
61 The Institute of Medical Science, Asahi Life Foundation Chuo-ku Tokyo Japan 103-0002
62 Hachioji Diabetes Clinic Hachioji Tokyo Japan 192-0083
63 Clinic Masae Minami Fukuoka Japan 815-0071
64 Jinnouchi Hospital Kumamoto Japan 862-0976
65 Heiwadai Hospital Miyazaki Japan 880-0034
66 Abe Clinic Oita Japan 870-0039
67 Gabinety TERPA Lublin Lubelskie Poland 20-333
68 NZOZ Medica Lublin Lubelskie Poland 20-538
69 Centrum Medyczne "Diabetika" Radom Mazowieckie Poland 26-600
70 NBR Polska Warszawa Mazowieckie Poland 00-465
71 Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa Mazowieckie Poland 02-507
72 Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET Krakow Małopolskie Poland 31-261
73 SN ZOZ Lege Artis Poradnia Diabetologiczna Bialystok Podlaskie Poland 15-404
74 NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny Bialystok Podlaskie Poland 15-435
75 Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie Poland 80-546
76 Private Practice - Dr. Janusz Gumprecht Zabrze Śląskie Poland 41-800
77 Advanced Clinical Research, LLC Bayamon Puerto Rico 00960
78 Private Practice Dr. Martha Gomez Cuellar San Juan Puerto Rico 00921
79 Tatratrial s.r.o. Rožňava Košický Kraj Slovakia 04801
80 FUNKYSTUFF s.r.o. Nove Zamky Nitriansky Kraj Slovakia 940 02
81 ENDIAMED s.r.o Dolny Kubin Žilinský Kraj Slovakia 026 01
82 Changhua Christian Hospital Changhua County Changhua Taiwan 50006
83 Chung Shan Medical University Hospital Taichung City Taichung Taiwan 402
84 Taichung Veterans General Hospital Taichung City Taichung Taiwan 40705
85 Chi Mei Medical Center Tainan City Tainan Taiwan 71004
86 Taipei Veterans General Hospital Taipei City Taipei Taiwan 112
87 National Cheng-Kung Uni. Hosp. Tainan Taiwan 704

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Chair: 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:
NCT05463744
Other Study ID Numbers:
  • 18263
  • I8H-MC-BDCY
  • 2021-005892-38
First Posted:
Jul 19, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 15, 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
Keywords provided by Eli Lilly and Company
Type 1 Diabetes (T1D)
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Insulin

Study Results

No Results Posted as of Aug 18, 2022