Clinical trial NCT03018938: A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
Official title: Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: mid mixture insulin analog
basal insulin analog
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 24 Weeks
Secondary outcomes:
measure: Change From Baseline to Week 48 in HbA1c
timeFrame: Baseline, 48 Weeks
measure: Percentage of Participants Who Achieve HbA1c <7% at Week 24
timeFrame: 24 Weeks
measure: Percentage of Participants Who Achieve HbA1c <7% at Week 48
timeFrame: 48 Weeks
measure: Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
timeFrame: Baseline, 48 Weeks
measure: Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
timeFrame: Baseline, 48 Weeks
measure: Total Daily Insulin Dose at Week 24 and 48
timeFrame: 24 Weeks, 48 Weeks
measure: Change From Baseline to Week 24 in Body Weight
timeFrame: Baseline, 24 Weeks
measure: Change From Baseline to Week 48 in Body Weight
timeFrame: Baseline, 48 Weeks
measure: Rate of Hypoglycemia at Week 24 and 48
timeFrame: 24 Weeks, 48 Weeks
measure: Number of Participants With Insulin Treatment Change at Week 48
timeFrame: Baseline through 48 Weeks
measure: Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
timeFrame: 24 Weeks
measure: Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
timeFrame: 48 Weeks
measure: Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
timeFrame: Baseline, 48 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Huaxin Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
city: Chaoyang
country: China
facility: China Meitan General Hospital
state: Beijing
city: Fangshan
country: China
facility: Beijing Yanhua hospital
state: Beijing
city: Lanzhou
country: China
facility: The 2nd Hospital of Lanzhou University
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen City People Hospital
state: Guangdong
city: Yuexiu
country: China
facility: The 1st Hospital with Guangdong Pharmaceutical University
state: Guangdong
city: Luoyang
country: China
facility: The 1st Affiliated Hospital of Henan Science and technology
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province
state: Henan
city: Wuhan
country: China
facility: Wuhan Union (Xiehe) Hospital
state: Hubei
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing TCM hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiang Su Province Official Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangbei Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou City People Hospital
state: Jiangsu
city: Wuxi
country: China
facility: The second People's hospital of Wuxi
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou central Hospital
state: Jiangsu
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Taian
country: China
facility: Taian City Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Pudong New Area Gongli Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New District Zhoupu Hospital
state: Shanghai
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Shunqing
city: Chengdu
country: China
facility: The Third Affiliated Hospital of Chengdu University of TCM
state: Sichuan
city: Luzhou
country: China
facility: Southwest Medical University Affiliated Hospital
state: Sichuan
city: Nankai
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Beijing
country: China
facility: Beijing LuHe Hospital Capital Medical University
state: Tongzhou
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University International Hospital
city: Beijing
country: China
facility: Beijing Hai Dian Hospital
city: Shanghai
country: China
facility: Shanghai Yangpu District Central Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.