A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
NCT ID: NCT03338010
Last Updated: 2021-05-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
536 participants
INTERVENTIONAL
2018-03-22
2020-03-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
NCT03338023
A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants
NCT03555305
A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus
NCT02302716
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
NCT01374178
A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants
NCT01688635
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LY2963016
Insulin 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).
LY2963016
Administered SC
Lantus®
Insulin 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.
Lantus®
Administered SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LY2963016
Administered SC
Lantus®
Administered SC
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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
Explore where the study is taking place and check the recruitment status at each participating site.
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, China
Siping central people's hospital
Siping, Jilin, China
Dalian Med. Univ. No 2 Affiliate Hospital
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 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
Wuhan Central Hospital
Wuhan, Hubei, China
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
Wuhan, Hubei, China
The First People Hospital of Yueyang
Yueyang, Hunan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
The Affliated Jiangyin Hospital of Southeast University Medical College
Jiangyin, Jiangsu, China
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Xuzhou central Hospital
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical Universit
Nanjing, Nanjing, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Jinan Central Hospital
Jinan, Shandong, China
1st affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Peking Union Medical College Hospital
Beijing, , China
Chongqing General Hospital
Chongqing, , China
Shanghai Putuo District Center Hospital
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I4L-GH-ABET
Identifier Type: OTHER
Identifier Source: secondary_id
16037
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.