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A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05662332
Collaborator
(none)
670
Enrollment
72
Locations
2
Arms
17.8
Anticipated Duration (Months)
9.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine the efficacy and safety of LY3209590 administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.

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)
Masking Description:
Sponsor will be blinded throughout the study.
Primary Purpose:
Treatment
Official Title:
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes
Actual Study Start Date :
Jan 14, 2023
Anticipated Primary Completion Date :
Jul 8, 2024
Anticipated Study Completion Date :
Jul 8, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3209590

Participants will receive LY3209590 subcutaneously (SC) once weekly.

Drug: LY3209590
Administered SC
Active Comparator: Insulin Glargine

Participants will receive insulin glargine SC once daily.

Drug: Insulin Glargine
Administered SC

Outcome Measures

Primary Outcome Measures

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

    Demonstrate noninferiority of LY3209590 compared to insulin glargine

Secondary Outcome Measures

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

    Demonstrate superiority of LY3209590 compared to insulin glargine

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

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

  3. Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence [Week 52]

    Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.

  4. Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence [Week 52]

    Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.

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

  6. Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction [Baseline, Week 52]

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

  7. Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) [Baseline, Week 52]

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

  8. Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity [Baseline, Week 52]

    SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication).

  9. Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics [Baseline, Week 52]

    DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes.

Eligibility Criteria

Criteria

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

  • Have a diagnosis of T2D according to the World Health Organization criteria.

  • Have an HbA1c of 7.0% to 10.0%, 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.

  • Are insulin naive

Exceptions:

  • short-term insulin treatment for a maximum of 14 days, prior to screening, and

  • prior insulin treatment for gestational diabetes.

Exclusion Criteria:

  • Have a diagnosis of type 1 diabetes (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 Cahaba Research Birmingham Alabama United States 35242
2 Syed Research Consultants Llc Sheffield Alabama United States 35660
3 AMCR Institute Escondido California United States 92025
4 Velocity Clinical Research, Gardena Gardena California United States 90247
5 Velocity Clinical Research, Huntington Park Huntington Park California United States 90255
6 Velocity Clinical Research, Westlake Los Angeles California United States 90057
7 Diabetes Associates Medical Group Orange California United States 92868
8 Encompass Clinical Research Spring Valley California United States 91978
9 Millennium Clinical Trials Thousand Oaks California United States 91360
10 University Clinical Investigators, Inc. Tustin California United States 92780
11 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
12 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045
13 Chase Medical Research, LLC Waterbury Connecticut United States 06708
14 Clinical Research of West Florida, Inc. (Clearwater) Clearwater Florida United States 33765
15 Suncoast Research Group Miami Florida United States 33135
16 Clinical Research of West Florida Tampa Florida United States 33606
17 Center for Advanced Research & Education Gainesville Georgia United States 30501
18 Pacific Diabetes & Endocrine Center Honolulu Hawaii United States 96813
19 Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Springfield Illinois United States 62711
20 American Health Network of Indiana, LLC - Franklin Franklin Indiana United States 46131
21 American Health Network of Indiana, LLC - Muncie Muncie Indiana United States 47304
22 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
23 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
24 Clinvest Research LLC Springfield Missouri United States 65807
25 University Of Nebraska Medical Center Omaha Nebraska United States 68198-4130
26 Mid Hudson Medical Research New Windsor New York United States 12553
27 Meridian Clinical Research, LLC Vestal New York United States 13850
28 Alliance for Multispecialty Research, LLC Norman Oklahoma United States 73069
29 Cascade Physicians Tualatin Oregon United States 97062
30 Diabetes & Endocrinology Consultants of Pennsylvania, LLC Feasterville-Trevose Pennsylvania United States 19053
31 Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) Pittsburgh Pennsylvania United States 15236
32 WR-Clinsearch, LLC Chattanooga Tennessee United States 37397
33 Private Practice - Dr. Osvaldo A. Brusco Corpus Christi Texas United States 78414
34 Velocity Clinical Research, Dallas Dallas Texas United States 75230
35 Prime Revival Research Institute Flower Mound Texas United States 75028
36 Endocrine Associates Houston Texas United States 77004
37 Endocrine Ips, Pllc Houston Texas United States 77079
38 North Hills Family Medicine/North Hills Medical Research North Richland Hills Texas United States 76180
39 Texas Valley Clinical Research Weslaco Texas United States 78596
40 Eastside Research Associates Redmond Washington United States 98052
41 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina 1056
42 Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires Argentina 7600
43 DIM Clínica Privada Ramos Mejía Buenos Aires Argentina B1704ETD
44 Go Centro Medico San Nicolás San Nicolas Buenos Aires Argentina 2900
45 Asociación de Beneficencia Hospital Sirio Libanés Buenos Aires Buenos Air Argentina C1419AHN
46 Stat Research S.A. Capital Federal Buenos Air Argentina 1023
47 Centro Médico Viamonte Buenos Aires Ciudad Aut Argentina C1120AAC
48 Glenny Corp Buenos Aires Ciudad Aut Argentina C1430CKE
49 CEMEDIAB C.a.b.a. Ciudad Aut Argentina C1205AAO
50 Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1179AAB
51 CIPREC Caba Ciudad Autónoma De Buenos Aire Argentina C1061AAS
52 Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire Argentina C1425AGC
53 Centro Medico Privado San Vicente Diabetes Cordoba Córdoba Argentina 5006
54 Instituto Médico Río Cuarto Río Cuarto Córdoba Argentina 5800
55 CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Godoy Cruz Mendoza Argentina M5501ARP
56 Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica Rosario Santa Fe Argentina 2000
57 Clínica Mayo San Miguel de Tucuman Tucumán Argentina 4000
58 Fundación Respirar Buenos Aires Argentina C1426ABP
59 CENUDIAB Ciudad Autónoma de Buenos Aire Argentina C1440AAD
60 Centro de Diagnóstico y Rehabilitación (CEDIR) Santa Fe Argentina 3000
61 Sanatorio Norte Santiago del Estero Argentina 4200
62 RM Pharma Specialists Mexico City Distrito Federal Mexico 3100
63 Instituto Jalisciense de Investigacion en Diabetes y Obesidad Guadalajara Jalisco Mexico 04460
64 Diseno y Planeacion en Investigacion Medica Guadalajara Jalisco Mexico 44130
65 Instituto de Diabetes, Obesidad y Nutricion Cuernavaca Morelos Mexico 62250
66 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 64460
67 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
68 Unidad Médica para la Salud Integral San Nicolás de los Garza Nuevo León Mexico 66465
69 Medical Care and Research SA de CV Merida Yucatán Mexico 97070
70 Investigacion En Salud Y Metabolismo Sc Chihuahua Mexico 31217
71 Ponce Medical School Foundation Inc. Ponce Puerto Rico 00716
72 Latin Clinical Trial Center San Juan Puerto Rico 00909

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:
NCT05662332
Other Study ID Numbers:
  • 18261
  • I8H-MC-BDCW
First Posted:
Dec 22, 2022
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
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 Glargine

Study Results

No Results Posted as of Jan 27, 2023