A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
NCT ID: NCT03952143
Last Updated: 2022-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
628 participants
INTERVENTIONAL
2019-05-27
2021-01-20
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
Participants received 100 U/mL insulin lispro (Humalog) given 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 been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.
* Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).
* Participants must have a HbA1c ≥7.0% and ≤11.0%.
* Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).
Exclusion Criteria
* Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.
* Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
* Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days 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 Médico Viamonte
Buenos Aires, AR-C, Argentina
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, , Argentina
Beijing Pinggu District Hospital
Beijing, Cn-11, China
Tianjin Medical University General Hospital
Tianjin, Cn-12, China
Cangzhou People's Hospital
Cangzhou, Cn-13, China
The First Hospital of Qinhuangdao
Qinhuangdao Shi, Cn-13, China
Inner Mongolia People's Hospital
Hohhot, Cn-15, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Cn-21, China
Shengjing Hospital of China Medical University
Shenyang, Cn-21, China
Shanghai Putuo District Center Hospital
Shanghai, Cn-31, China
Shanghai 6th people's hospital
Shanghai, Cn-31, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
Jiangyin, Cn-32, China
Zhongda Hospital Southeast University
Nanjing, Cn-32, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Cn-32, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Cn-32, China
The Third Hospital of Nanchang
Nanchang, Cn-36, China
The Central Hospital of Wuhan
Wuhan, Cn-42, China
The First People's Hospital of Yueyang
Yueyang, Cn-43, China
Chongqing General Hospital
Chongqing, Cn-50, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Xingtai People's Hospital
Xingtai, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
Wuhan Pu'ai Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
The First Hospital of Nanjing
Nanjing, Jiangsu, China
China-Japan Union Hospital, CJUH.
Changchun, Jilin, China
Siping Central People's Hospital
Siping, Jilin, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Jinan Central Hospital
Jinan, Shandong, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Beijing Peking Union Medical College Hospital
Beijing, , China
Pingxiang People's Hospital
Pingxiang, , China
Unidad de patologia Clinica
Guadalajara, Jalisco, Mexico
Centro de Inv. Medica de Occidente, SC
Zapopan, Jalisco, Mexico
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Mx-nle, 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 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Other Identifiers
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I8B-FH-ITSE
Identifier Type: OTHER
Identifier Source: secondary_id
16830
Identifier Type: -
Identifier Source: org_study_id
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