A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

— CLASSIC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018938
• Other study ID #: 16507
• Secondary ID: F3Z-GH-IOQR
• Status: Completed
• Phase: Phase 4
• Start date: February 6, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: August 15, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: July 12, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin Analog Mid Mixture
Administered SC
• Basal Insulin Analog
Administered SC

Locations

Country	Name	City	State
China	Beijing Hai Dian Hospital	Beijing
China	Beijing Huaxin Hospital	Beijing	Beijing
China	Beijing LuHe Hospital Capital Medical University	Beijing	Tongzhou
China	Peking University International Hospital	Beijing
China	Peking University Peoples Hospital	Beijing	Beijing
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	China Meitan General Hospital	Chaoyang	Beijing
China	The Third Affiliated Hospital of Chengdu University of TCM	Chengdu	Sichuan
China	Beijing Yanhua hospital	Fangshan	Beijing
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The 2nd Hospital of Lanzhou University	Lanzhou	Gansu
China	The 1st Affiliated Hospital of Henan Science and technology	Luoyang	Henan
China	Southwest Medical University Affiliated Hospital	Luzhou	Sichuan
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Shunqing
China	Jiang Su Province Official Hospital	Nanjing	Jiangsu
China	Nanjing Jiangbei Hospital	Nanjing	Jiangsu
China	Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	Nanjing TCM hospital	Nanjing	Jiangsu
China	Tianjin First Central Hospital	Nankai	Tianjin
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Shanghai Pudong New Area Gongli Hospital	Shanghai	Shanghai
China	Shanghai Pudong New District Zhoupu Hospital	Shanghai	Shanghai
China	Shanghai Yangpu District Central Hospital	Shanghai
China	Shenzhen City People Hospital	Shenzhen	Guangdong
China	Taian City Central Hospital	Taian	Shandong
China	Taizhou City People Hospital	Taizhou	Jiangsu
China	Wuhan Union (Xiehe) Hospital	Wuhan	Hubei
China	The second People's hospital of Wuxi	Wuxi	Jiangsu
China	Xuzhou central Hospital	Xuzhou	Jiangsu
China	The 1st Hospital with Guangdong Pharmaceutical University	Yuexiu	Guangdong
China	People's Hospital of Henan Province	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to Week 48 in 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 ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.	Baseline, 48 Weeks
Secondary	Percentage of Participants Who Achieve HbA1c <7% at Week 24	Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.	24 Weeks
Secondary	Percentage of Participants Who Achieve HbA1c <7% at Week 48	Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.	48 Weeks
Secondary	Change From Baseline to Week 24 in Venous Fasting Plasma Glucose	Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.	Baseline, 24 Weeks
Secondary	Change From Baseline to Week 48 in Venous Fasting Plasma Glucose	Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.	Baseline, 48 Weeks
Secondary	Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose	Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.	Baseline, 24 Weeks
Secondary	Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose	Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.	Baseline, 48 Weeks
Secondary	Total Daily Insulin Dose at Week 24 and 48	Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.	24 Weeks, 48 Weeks
Secondary	Change From Baseline to Week 24 in Body Weight	LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.	Baseline, 24 Weeks
Secondary	Change From Baseline to Week 48 in Body Weight	LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.	Baseline, 48 Weeks
Secondary	Rate of Hypoglycemia at Week 24 and 48	Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of =70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.	24 Weeks, 48 Weeks
Secondary	Number of Participants With Insulin Treatment Change at Week 48	Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.; Discontinuation: Defined as stopping insulin treatment for 30 days or more.; Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.; Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group; Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.	Baseline through 48 Weeks
Secondary	Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24	Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.	24 Weeks
Secondary	Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48	Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.	48 Weeks
Secondary	Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score	The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.	Baseline, 48 Weeks