QWINT-4: A Study of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05462756

Collaborator

(none)

670

Enrollment

Locations

Arms

14.2

Anticipated Duration (Months)

8.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of once-weekly LY3209590 compared with daily insulin glargine in participants with type 2 diabetes (T2D).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Type 2 Diabetes Treated With Insulin	Drug: LY3209590 Drug: Insulin Lispro (U100) Drug: Insulin Glargine (U100)	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, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections

Actual Study Start Date :

Aug 11, 2022

Anticipated Primary Completion Date :

Oct 17, 2023

Anticipated Study Completion Date :

Oct 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3209590 + Insulin Lispro Participants will be given LY3209590 by subcutaneous (SC) injection along with insulin lispro	Drug: LY3209590 Administered SC Drug: Insulin Lispro (U100) Administered SC Other Names: Humalog
Active Comparator: Insulin Glargine + Insulin Lispro Participants will be given insulin glargine by SC injection along with insulin lispro	Drug: Insulin Lispro (U100) Administered SC Other Names: Humalog Drug: Insulin Glargine (U100) Administered SC Other Names: Basaglar

Arm

Intervention/Treatment

Experimental: LY3209590 + Insulin Lispro

Participants will be given LY3209590 by subcutaneous (SC) injection along with insulin lispro

Drug: LY3209590

Administered SC

Drug: Insulin Lispro (U100)

Administered SC

Other Names:

Humalog

Active Comparator: Insulin Glargine + Insulin Lispro

Participants will be given insulin glargine by SC injection along with insulin lispro

Drug: Insulin Lispro (U100)

Administered SC

Other Names:

Humalog

Drug: Insulin Glargine (U100)

Administered SC

Other Names:

Basaglar

Outcome Measures

Primary Outcome Measures

Change from Baseline in HbA1c [Baseline, Week 26]
Change from Baseline in HbA1c of LY3209590 compared to insulin glargine on glycemic control in adult participants with type 2 diabetes on multiple daily injections.

Secondary Outcome Measures

Percentage of Participants Achieving HbA1c <7% without Nocturnal Hypoglycemia [Week 26]
Percentage of participants achieving HbA1c <7% without nocturnal hypoglycemia milligram/deciliter (mg/dL) [3.0 millimole/Liter (mmol/L) or severe] during treatment phase up to week 26.
Nocturnal Hypoglycemia Event Rate [Baseline to Week 26]
The event rate of participant-reported clinically significant nocturnal hypoglycemia <54 mg/dL (3.0 mmol/L) or severe) measured during treatment phase up to week 26.
Change from Baseline in Fasting Glucose [Baseline, Week 26]
Change from baseline in fasting glucose measured by small monitoring blood glucose (SMBG)
Time in Glucose Range [Week 22 to Week 26]
Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session
Time in Hypoglycemia Range [Week 22 to Week 26]
Time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L), measured by CGM
Time in Hyperglycemia Range [Week 22 to Week 26]
Time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L), measured by CGM
Glucose Variability [Week 22 to Week 26]
Glucose variability measured during the CGM session
Basal Insulin Dose [Week 26]
Bolus Insulin Dose [Week 26]
Total Insulin Dose [Week 26]
Basal Insulin Dose to Total Insulin Dose Ratio [Week 26]
Hypoglycemia Event Rate [Baseline to Week 26]
Incidence and rate of composite of level 2 and 3 hypoglycemia event
Change from Baseline in Body Weight [Baseline, Week 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
Are receiving ≥10 units of total basal insulin per day at screening.
Are receiving ≤2 units/kilogram/day of total daily insulin at screening
Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
once daily U-100 or U-200 insulin degludec
once daily U-100 or U-300 insulin glargine
once or twice daily U-100 insulin detemir or
once or twice daily human insulin Neutral Protamine Hagedorn
Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur prior to the evening meal.
Insulin lispro-aabc
Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
Insulin aspart (U-100)
Insulin glulisine (U-100), or
Regular insulin (U-100)
Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
dipeptidyl peptidase IV inhibitors
sodium-glucose co-transporter-2 inhibitors
biguanides (for example, metformin), or
glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
Have a body mass index ≤45 kilogram/square meter (kg/m²)

Exclusion Criteria:

Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).
Are currently receiving any of the following insulin therapies anytime in the past 90 days:
insulin mixtures
insulin human, inhalation powder, or
continuous subcutaneous insulin infusion therapy, or
regular insulin U-500
Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
Have hypoglycemia unawareness in the opinion of the investigator
Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMR of Greater New Haven	Hamden	Connecticut	United States	06517
2	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
3	Panax Clinical Research	Miami Lakes	Florida	United States	33014
4	Encore Medical Research - Weston	Weston	Florida	United States	33331
5	Elite Clinical Trials	Blackfoot	Idaho	United States	83221
6	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
7	MedStar Good Samaritan Hospital	Baltimore	Maryland	United States	21239
8	NECCR PrimaCare Research	Fall River	Massachusetts	United States	02721
9	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan	United States	48098
10	Palm Research Center Tenaya	Las Vegas	Nevada	United States	89128
11	Palm Research Center Sunset	Las Vegas	Nevada	United States	89148
12	Research Foundation of SUNY - University of Buffalo	Buffalo	New York	United States	14221
13	Remington Davis Clinical Research	Columbus	Ohio	United States	43215
14	Aventiv Research	Dublin	Ohio	United States	43016
15	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania	United States	15009
16	Thomas Jefferson University - Clinical Research Institute	Philadelphia	Pennsylvania	United States	19107
17	Texas Diabetes & Endocrinology, P.A.	Austin	Texas	United States	78731
18	Texas Diabetes & Endocrinology, P.A.	Austin	Texas	United States	78749
19	North Texas Endocrine Center	Dallas	Texas	United States	75231
20	Biopharma Informatic, LLC	Houston	Texas	United States	77043
21	Research Institute of Dallas	Plano	Texas	United States	75093
22	Consano Clinical Research, LLC	Shavano Park	Texas	United States	78231
23	Chrysalis Clinical Research	Saint George	Utah	United States	84790
24	Rainier Clinical Research Center	Renton	Washington	United States	98057
25	CEDIC	Caba	Buenos Aires	Argentina	C1060ABN
26	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aire	Buenos Aires	Argentina	C1405BUB
27	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires	Argentina	1056
28	Go Centro Medico San Nicolás	San Nicolas	Buenos Aires	Argentina	2900
29	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aire	Argentina	C1061AAS
30	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aire	Argentina	C1128AAF
31	Instituto Centenario	Caba	Ciudad Autónoma De Buenos Aire	Argentina	1204
32	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire	Argentina	C1425AGC
33	Instituto Médico Río Cuarto	Río Cuarto	Córdoba	Argentina	5800
34	Centro de Salud e Investigaciones Médicas	Santa Rosa	La Pampa	Argentina	6300
35	Instituto de Investigaciones Clinicas Rosario	Rosario	Santa Fe	Argentina	2000
36	Instituto Médico Catamarca IMEC	Rosario	Santa Fe	Argentina	2000
37	Centro de Investigaciones Médicas Tucuman	SAN M. DE Tucuman	Tucumán	Argentina	T4000AXL
38	CENUDIAB	Ciudad Autónoma de Buenos Aire		Argentina	C1440AAD
39	Instituto de Investigaciones Clínicas Córdoba	Córdoba		Argentina	5000
40	Centro de Investigaciones Clinicas del Litoral	Santa Fe		Argentina	3000
41	ClinPhenomics CVC GmbH	Frankfurt	Hessen	Germany	60596
42	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen	Germany	45136
43	Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage	Münster	Nordrhein-Westfalen	Germany	48153
44	Institut für Diabetesforschung GmbH Münster	Münster	Nordrhein-	Germany	48145
45	RED-Institut GmbH	Oldenburg	Schleswig-Holstein	Germany	23758
46	Diabetespraxis Mergentheim	Bad Mergentheim		Germany	97980
47	Diabeteszentrum Hamburg West	Hamburg		Germany	22607
48	Life Care Hospital and Research Centre	Bangalore	Karnataka	India	560092
49	Topiwala National Medical College & B. Y. L. Nair Charitable Hospital	Mumbai	Maharashtra	India	400008
50	BSES MG Hospital	Mumbai	Maharashtra	India	400058
51	Madras Diabetes Research Foundation	Chennai	Tamil Nadu	India	600086
52	Osmania General Hospital	Hyderabad	Telangana	India	500012
53	Postgraduate Institute of Medical Education & Research	Chandigarh		India	160012
54	Osepdale Civile Fr 5	Ceccano	Frosinone	Italy	03023
55	Ospedale San Giovanni Calibita Fatebenefratelli	Roma	Lazio	Italy	00186
56	Ospedale Luigi Sacco	Milan	Milano	Italy	20157
57	Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino	Torino	Piemonte	Italy	10126
58	Ospedale san Giovanni di Dio-Diabetologia	Olbia	Sardegna	Italy	07026
59	INRCA Ancona	Ancona		Italy	60125
60	IRCCS - AOU di Bologna	Bologna		Italy	40138
61	Azienda Ospedaliera Spedali Civili di Brescia	Brescia		Italy	25123
62	Azienda Ospedaliera Mater Domini	Catanzaro		Italy	88100
63	Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli	Palermo		Italy	90127
64	Private Practice - Dr. Arechavaleta Granell Maria del Rosario	Guadalajara	Jalisco	Mexico	44670
65	Unidad de Investigación Clínica y Atención Médica HEPA	Guadalajara	Jalisco	Mexico	44670
66	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León	Mexico	66460
67	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León	Mexico	66465
68	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Ciudad Madero	Tamaulipas	Mexico	89440
69	Investigacion En Salud Y Metabolismo Sc	Chihuahua		Mexico	31217
70	Centro de Endocrinologia Alcantara Gonzalez	Bayamon		Puerto Rico	00959
71	Manati Center for Clinical Research	Manati		Puerto Rico	00674
72	Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [La Coruña]	Spain	15006
73	Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval	Ferrol	A Coruña [La Coruña]	Spain	15405
74	Hospital Universitario Virgen de la Victoria	Malaga	Andalucía	Spain	29010
75	Hospital Universitari Son Espases	Palma	Balears [Baleares]	Spain	07120
76	Hospital Clínico Universitario de Valladolid	Valladolid	Castilla Y León	Spain	47010
77	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya [Cataluña]	Spain	08041
78	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón	Madrid	Spain	28223
79	Vithas Hospital Sevilla	Seville	Sevilla	Spain	41950
80	Hospital Universitario de La Ribera	Alzira	Valenciana, Comunitat	Spain	46600
81	Hospital General Universitario de Valencia	Valencia	Valenciana, Comunitat	Spain	46014
82	Hospital Universitario San Cecilio	Granada		Spain	18016
83	Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)	Sevilla		Spain	41003