A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
NCT ID: NCT03952130
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2019-05-29
2022-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY900014
Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
LY900014
Administered SC
Insulin Glargine
Administered SC
Insulin Degludec
Administered SC
Insulin Lispro (Humalog)
Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
Insulin Lispro
Administered SC
Insulin Glargine
Administered SC
Insulin Degludec
Administered SC
Interventions
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LY900014
Administered SC
Insulin Lispro
Administered SC
Insulin Glargine
Administered SC
Insulin Degludec
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have HbA1c of ≥7.0 and ≤10.0%.
* Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily.
* Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).
Exclusion Criteria
* Participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening.
* Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, Argentina
Centro Médico Viamonte
CABA, Buenos Aires, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, , Argentina
The Second People's Hospital of Hefei
Hefei, Anhui, China
Dongguan people's hospital
Dongguan, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shantou University Medical College No.2 Affiliated Hospital
Shantou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
The First People's Hospital of Changde City
Changde, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The First Hospital of Nanjing
Nanjing, Jiangsu, China
Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Jiangsu Province Hospital
Nanjing, Nanjing, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Beijing Peking Union Medical College Hospital
Beijing, , China
Shanghai Putuo District Center Hospital
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
Guadalajara, Jalisco, Mexico
Unidad de patologia Clinica
Guadalajara, Jalisco, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, N.L., Mexico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Other Identifiers
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I8B-FH-ITSD
Identifier Type: OTHER
Identifier Source: secondary_id
16829
Identifier Type: -
Identifier Source: org_study_id
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