A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
NCT ID: NCT03018938
Last Updated: 2020-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
814 participants
INTERVENTIONAL
2017-02-06
2019-07-12
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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Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
Insulin Analog Mid Mixture
Administered SC
Basal Insulin Analog
Basal insulin analog given SC.
Basal Insulin Analog
Administered SC
Interventions
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Insulin Analog Mid Mixture
Administered SC
Basal Insulin Analog
Administered SC
Eligibility Criteria
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Inclusion Criteria
* are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
* most recent HbA1c value ≥7.5% within 12 weeks of study entry
* in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
* willing to start with insulin treatment
Exclusion Criteria
* have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
* have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
* are pregnant or breastfeeding, or intend to become pregnant during the course of the study
* are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
18 Years
80 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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Beijing Huaxin Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
China Meitan General Hospital
Chaoyang, Beijing Municipality, China
Beijing Yanhua hospital
Fangshan, Beijing Municipality, China
The 2nd Hospital of Lanzhou University
Lanzhou, Gansu, China
Shenzhen City People Hospital
Shenzhen, Guangdong, China
The 1st Hospital with Guangdong Pharmaceutical University
Yuexiu, Guangdong, China
The 1st Affiliated Hospital of Henan Science and technology
Luoyang, Henan, China
People's Hospital of Henan Province
Zhengzhou, Henan, China
Wuhan Union (Xiehe) Hospital
Wuhan, Hubei, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Nanjing TCM hospital
Nanjing, Jiangsu, China
Jiang Su Province Official Hospital
Nanjing, Jiangsu, China
Nanjing Jiangbei Hospital
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Taizhou City People Hospital
Taizhou, Jiangsu, China
The second People's hospital of Wuxi
Wuxi, Jiangsu, China
Xuzhou central Hospital
Xuzhou, Jiangsu, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Taian City Central Hospital
Taian, Shandong, China
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pudong New District Zhoupu Hospital
Shanghai, Shanghai Municipality, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Shunqing, China
The Third Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, China
Tianjin First Central Hospital
Nankai, Tianjin Municipality, China
Beijing LuHe Hospital Capital Medical University
Beijing, Tongzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Peking University International Hospital
Beijing, , China
Beijing Hai Dian Hospital
Beijing, , China
Shanghai Yangpu District Central Hospital
Shanghai, , China
Countries
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References
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Zeng T, Yuan H, Ren J, Li Y, Hou J, Du L, Zhu J, Chen L, Ji L. A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience. Diabetes Ther. 2021 Mar;12(3):931-941. doi: 10.1007/s13300-021-01007-z. Epub 2021 Feb 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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F3Z-GH-IOQR
Identifier Type: OTHER
Identifier Source: secondary_id
16507
Identifier Type: -
Identifier Source: org_study_id
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