A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus® in Adult Chinese Patients With Type 2 Diabetes Mellitus
2 other identifiers
interventional
536
1 country
32
Brief Summary
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Mar 2018
Typical duration for phase_3 type-2-diabetes
32 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 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2020
CompletedResults Posted
Study results publicly available
May 25, 2021
CompletedMay 25, 2021
May 1, 2021
2 years
November 7, 2017
March 15, 2021
May 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model.
Baseline, Week 24
Secondary Outcomes (11)
Change From Baseline in HbA1c (Lantus® 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% at Week 24
Week 24
Percentage of Participants With HbA1c ≤6.5% at Week 24
Week 24
Change From Baseline in Glycemic Variability of Fasting Blood Glucose
Baseline, Week 24
- +6 more secondary outcomes
Study Arms (2)
LY2963016
EXPERIMENTALInsulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤100 milligram per deciliter (mg/dL) (5.6 millimoles per litre \[mmol/L\]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM).
Lantus®
ACTIVE COMPARATORInsulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Interventions
Eligibility Criteria
You may qualify if:
- Have T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification.
- Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening.
- Have a HbA1c ≥7.0% and ≤11.0%.
- Body mass index (BMI) ≤35 kilograms per meter squared.
You may not qualify if:
- Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks.
- Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
- Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
- Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- Have had ≥2 emergency room visits or hospitalizations due to poor glucose control.
- Have known hypersensitivity or allergy to Lantus® or its excipients.
- Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have received such therapy within 4 weeks immediately preceding screening.
- Have obvious signs or symptoms, or laboratory evidence, of liver disease.
- Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease.
- Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 milligrams per deciliter.
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
- Participants with active cancer or personal history of cancer within the previous 5 years.
- Are pregnant or intend to become pregnant during the course of the study.
- Are women who are breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000, 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
Wuhan Central Hospital
Wuhan, Hubei, 430014, China
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
Wuhan, Hubei, 430030, China
The First People Hospital of Yueyang
Yueyang, Hunan, 414000, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003, China
The Affliated Jiangyin Hospital of Southeast University Medical College
Jiangyin, Jiangsu, 214400, China
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing, Jiangsu, 210008, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211199, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Xuzhou central Hospital
Xuzhou, Jiangsu, 221009, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041, China
Siping central people's hospital
Siping, Jilin, 136000, China
Dalian Med. Univ. No 2 Affiliate Hospital
Dalian, Liaoning, 116023, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110022, China
The First Affiliated Hospital with Nanjing Medical Universit
Nanjing, Nanjing, 210029, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
1st affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Peking Union Medical College Hospital
Beijing, 88798, China
Chongqing General Hospital
Chongqing, 400013, China
Shanghai Putuo District Center Hospital
Shanghai, 200062, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
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 22, 2018
Primary Completion
March 18, 2020
Study Completion
March 18, 2020
Last Updated
May 25, 2021
Results First Posted
May 25, 2021
Record last verified: 2021-05
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 European union (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 a signed data sharing agreement.