A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
CLASSIC
Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)
2 other identifiers
interventional
814
1 country
32
Brief Summary
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Feb 2017
Typical duration for phase_4 type-2-diabetes-mellitus
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
January 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedStudy Start
First participant enrolled
February 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedResults Posted
Study results publicly available
March 18, 2020
CompletedMarch 18, 2020
August 15, 2019
2 years
January 11, 2017
January 31, 2020
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
Baseline, 24 Weeks
Secondary Outcomes (15)
Change From Baseline to Week 48 in HbA1c
Baseline, 48 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 24
24 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 48
48 Weeks
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Baseline, 24 Weeks
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Baseline, 48 Weeks
- +10 more secondary outcomes
Study Arms (2)
Insulin Analog Mid Mixture
EXPERIMENTALInsulin analog mid mixture given subcutaneously (SC).
Basal Insulin Analog
EXPERIMENTALBasal insulin analog given SC.
Interventions
Eligibility Criteria
You may qualify if:
- have type 2 diabetes as defined by World Health Organization (WHO) 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
You may not qualify if:
- have a diagnosis of type 1 diabetes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Beijing Huaxin Hospital
Beijing, Beijing Municipality, 100016, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
China Meitan General Hospital
Chaoyang, Beijing Municipality, 100028, China
Beijing Yanhua hospital
Fangshan, Beijing Municipality, 102500, China
The 2nd Hospital of Lanzhou University
Lanzhou, Gansu, 730030, China
Shenzhen City People Hospital
Shenzhen, Guangdong, 518020, China
The 1st Hospital with Guangdong Pharmaceutical University
Yuexiu, Guangdong, 510080, China
The 1st Affiliated Hospital of Henan Science and technology
Luoyang, Henan, 471003, China
People's Hospital of Henan Province
Zhengzhou, Henan, 450003, China
Wuhan Union (Xiehe) Hospital
Wuhan, Hubei, 430022, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003, China
Nanjing TCM hospital
Nanjing, Jiangsu, 210001, China
Jiang Su Province Official Hospital
Nanjing, Jiangsu, 210024, China
Nanjing Jiangbei Hospital
Nanjing, Jiangsu, 210048, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100, China
Taizhou City People Hospital
Taizhou, Jiangsu, 225300, China
The second People's hospital of Wuxi
Wuxi, Jiangsu, 214000, China
Xuzhou central Hospital
Xuzhou, Jiangsu, 221009, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266071, China
Taian City Central Hospital
Taian, Shandong, 271000, China
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, 200135, China
Shanghai Pudong New District Zhoupu Hospital
Shanghai, Shanghai Municipality, 201318, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Shunqing, 637000, China
The Third Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610041, China
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, 646000, China
Tianjin First Central Hospital
Nankai, Tianjin Municipality, 300192, China
Beijing LuHe Hospital Capital Medical University
Beijing, Tongzhou, 101149, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
Peking University International Hospital
Beijing, 102206, China
Beijing Hai Dian Hospital
Beijing, China
Shanghai Yangpu District Central Hospital
Shanghai, 200090, China
Related Publications (1)
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.
PMID: 33616875DERIVED
MeSH Terms
Conditions
Condition 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 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2017
First Posted
January 12, 2017
Study Start
February 6, 2017
Primary Completion
February 19, 2019
Study Completion
July 12, 2019
Last Updated
March 18, 2020
Results First Posted
March 18, 2020
Record last verified: 2019-08-15
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 a signed data sharing agreement.