A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
NCT ID: NCT03338023
Last Updated: 2021-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2018-03-23
2020-03-05
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
NONE
Study Groups
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LY2963016 + Insulin Lispro
Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
LY2963016
Administered SC
Insulin Lispro
Administered SC
Lantus® + Insulin Lispro
Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Lantus®
Administered SC
Insulin Lispro
Administered SC
Interventions
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LY2963016
Administered SC
Lantus®
Administered SC
Insulin Lispro
Administered SC
Eligibility Criteria
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Inclusion Criteria
* Have duration of T1DM ≥1 year.
* Have HbA1c ≤11 %.
* Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening.
* Have a body mass index (BMI) ≤35 kilograms per meter squared.
Exclusion Criteria
* Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
* Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
* Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins.
* Are pregnant, intend to become pregnant during the course of the study.
* Women who are breastfeeding.
* Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
* Have congestive heart failure Class III and IV.
* Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.
* Have any active cancer.
* Have a history or diagnosis of human immunodeficiency virus (HIV) infection.
* Have presence of clinically significant gastrointestinal disease.
* Have a history of renal transplantation, or are currently receiving renal dialysis.
* Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.
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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Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Guangdong Province People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, 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
The 1st Affiliated Hospital of Henan Science and technology
Luoyang, Henan, China
Wu Han Tongji Hospital
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, China
Dalian Med. Univ. No 2 Affiliate Hospital
Dalian, Liaoning, China
The First Affiliated Hospital with Nanjing Medical Universit
Nanjing, Nanjing, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Peking Union Medical College Hospital
Beijing, , China
Shanghai Putuo District Center Hospital
Shanghai, , China
Countries
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References
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Yan X, Feng C, Lou Y, Zhou Z. Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus(R)): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial. Diabetes Ther. 2022 Jun;13(6):1161-1174. doi: 10.1007/s13300-022-01262-8. Epub 2022 Apr 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I4L-GH-ABES
Identifier Type: OTHER
Identifier Source: secondary_id
16036
Identifier Type: -
Identifier Source: org_study_id
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