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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Insulin Analog Mid Mixture
Basal Insulin Analog
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring mid mixture insulin analog, basal insulin analog

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Insulin Analog Mid Mixture

Basal Insulin Analog

Arm Description

Insulin analog mid mixture given subcutaneously (SC).

Basal insulin analog given SC.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 11, 2017
Last Updated
March 6, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03018938
Brief Title
A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 15, 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
February 19, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
mid mixture insulin analog, basal insulin analog

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
814 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Analog Mid Mixture
Arm Type
Experimental
Arm Description
Insulin analog mid mixture given subcutaneously (SC).
Arm Title
Basal Insulin Analog
Arm Type
Experimental
Arm Description
Basal insulin analog given SC.
Intervention Type
Drug
Intervention Name(s)
Insulin Analog Mid Mixture
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Basal Insulin Analog
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Description
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.
Time Frame
Baseline, 24 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 48 in HbA1c
Description
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.
Time Frame
Baseline, 48 Weeks
Title
Percentage of Participants Who Achieve HbA1c <7% at Week 24
Description
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time Frame
24 Weeks
Title
Percentage of Participants Who Achieve HbA1c <7% at Week 48
Description
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time Frame
48 Weeks
Title
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Description
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.
Time Frame
Baseline, 24 Weeks
Title
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Description
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.
Time Frame
Baseline, 48 Weeks
Title
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Description
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.
Time Frame
Baseline, 24 Weeks
Title
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Description
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.
Time Frame
Baseline, 48 Weeks
Title
Total Daily Insulin Dose at Week 24 and 48
Description
Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
Time Frame
24 Weeks, 48 Weeks
Title
Change From Baseline to Week 24 in Body Weight
Description
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.
Time Frame
Baseline, 24 Weeks
Title
Change From Baseline to Week 48 in Body Weight
Description
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.
Time Frame
Baseline, 48 Weeks
Title
Rate of Hypoglycemia at Week 24 and 48
Description
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.
Time Frame
24 Weeks, 48 Weeks
Title
Number of Participants With Insulin Treatment Change at Week 48
Description
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.
Time Frame
Baseline through 48 Weeks
Title
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Description
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.
Time Frame
24 Weeks
Title
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Description
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.
Time Frame
48 Weeks
Title
Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
Description
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.
Time Frame
Baseline, 48 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Huaxin Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100016
Country
China
Facility Name
Peking University Peoples Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
China Meitan General Hospital
City
Chaoyang
State/Province
Beijing
ZIP/Postal Code
100028
Country
China
Facility Name
Beijing Yanhua hospital
City
Fangshan
State/Province
Beijing
ZIP/Postal Code
102500
Country
China
Facility Name
The 2nd Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
Shenzhen City People Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
The 1st Hospital with Guangdong Pharmaceutical University
City
Yuexiu
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The 1st Affiliated Hospital of Henan Science and technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
People's Hospital of Henan Province
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Wuhan Union (Xiehe) Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Nanjing TCM hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210001
Country
China
Facility Name
Jiang Su Province Official Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210024
Country
China
Facility Name
Nanjing Jiangbei Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210048
Country
China
Facility Name
Nanjing Jiangning Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211100
Country
China
Facility Name
Taizhou City People Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Facility Name
The second People's hospital of Wuxi
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Facility Name
Xuzhou central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Taian City Central Hospital
City
Taian
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Facility Name
Shanghai Pudong New Area Gongli Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200135
Country
China
Facility Name
Shanghai Pudong New District Zhoupu Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201318
Country
China
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Shunqing
ZIP/Postal Code
637000
Country
China
Facility Name
The Third Affiliated Hospital of Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Southwest Medical University Affiliated Hospital
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China
Facility Name
Tianjin First Central Hospital
City
Nankai
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
Beijing LuHe Hospital Capital Medical University
City
Beijing
State/Province
Tongzhou
ZIP/Postal Code
101149
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
Peking University International Hospital
City
Beijing
ZIP/Postal Code
102206
Country
China
Facility Name
Beijing Hai Dian Hospital
City
Beijing
Country
China
Facility Name
Shanghai Yangpu District Central Hospital
City
Shanghai
ZIP/Postal Code
200090
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
33616875
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.
Results Reference
derived

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

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