A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus
2 other identifiers
interventional
272
1 country
20
Brief Summary
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2018
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2017
CompletedFirst Posted
Study publicly available on registry
November 9, 2017
CompletedStudy Start
First participant enrolled
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedResults Posted
Study results publicly available
March 29, 2021
CompletedMarch 29, 2021
April 15, 2020
2 years
November 7, 2017
March 3, 2021
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated using mixed-effects model for repeated measures (MMRM) with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares).
Baseline, Week 24
Secondary Outcomes (12)
Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016)
Baseline, Week 24
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
Baseline, Week 24
Percentage of Participants With HbA1c <7%
Week 24
Percentage of Participants With HbA1c ≤6.5%
Week 24
Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG
Baseline, Week 24
- +7 more secondary outcomes
Study Arms (2)
LY2963016 + Insulin Lispro
EXPERIMENTALParticipants 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.
Lantus® + Insulin Lispro
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Have T1DM based on the disease diagnostic criteria (World Health Organization \[WHO\] Classification).
- 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.
You may not qualify if:
- Exposure to an insulin glargine other than Lantus® within previous 30 days.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
Guangdong Province People's Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, Guangdong, 510080, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
Shantou University Medical College No.2 Affiliated Hospital
Shantou, Guangdong, 515041, China
The 1st Affiliated Hospital of Henan Science and technology
Luoyang, Henan, 471003, China
Wu Han Tongji Hospital
Wuhan, Hubei, 430030, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041, China
Dalian Med. Univ. No 2 Affiliate Hospital
Dalian, Liaoning, 116023, China
The First Affiliated Hospital with Nanjing Medical Universit
Nanjing, Nanjing, 210029, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034, China
Peking Union Medical College Hospital
Beijing, 88798, China
Shanghai Putuo District Center Hospital
Shanghai, 200062, China
Related Publications (1)
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.
PMID: 35471721DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2017
First Posted
November 9, 2017
Study Start
March 23, 2018
Primary Completion
March 5, 2020
Study Completion
March 5, 2020
Last Updated
March 29, 2021
Results First Posted
March 29, 2021
Record last verified: 2020-04-15
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and asigned data sharing agreement.