Observational Registry for Basal Insulin Treatment Study (ORBIT)

A Prospective, Observational Registry Study Focusing on the Real World Use, Effectiveness and Safety of Initial Basal Insulin Regimen in Type 2 Diabetic Patients Uncontrolled by Oral Antidiabetic Drugs in China

The scientific use of basal insulin is of great help to individuals and the government. However, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in China. This study is to evaluate the use of first basal insulin in China patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (OADs) from the naturalistic clinical practice.

Study Overview

• Status: Completed
• Conditions: Diabetes

Detailed Description

This is a 6-month multicentre, observational, prospective, registry study. About 200 hospitals from different parts of China will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12 months period.

The study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. The project will probably last for about 18 months.

• Study Type: Observational
• Enrollment (Actual): 19894

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University People's Hospital
    • Beijing, Beijing, China
      • Haidian hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients meet the following criteria, either from in-patient or out-patient department, will have chance to be enrolled in this study.

Description

Inclusion Criteria:

• 18-80 years old
• Type 2 diabetic patients
• Taking OADs before inclusion
• Recently tested HbA1c >=7% at the same site within 3 months
• Being suggested by physician to start basal insulin (BI) treatment
• Willing to start and having been prescribed BI treatment
• Willing to join the registry study and sign the informed consent

Exclusion Criteria:

• Diagnosed with type 1 diabetes
• Received any type of insulin in the last 2 years (except for the intermittent use of insulin of less than 1 month each time)
• With any severe health problem, or any other situation judged by the investigator, that is difficult for the 6 months follow-up
• Current or planned pregnant, lactating women
• Involved in other clinical trial simultaneously or at most 1 month before

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess the Change in HbA1c During the 6 Months Follow-up.	• Change of HbA1c from baseline to the end-point (6 month).	Baseline and 6 months
the Change of Hypoglycemia During Follow-up.	•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the FPG Change From Visit 1 to Visit 3	the FPG change = the FPG level at visit 1- the FPG level at visit 3	baseline and 6 months
the FPG Control Rate at Visit 3	the percentage of patients who had the FPG level <7.0 mmol/L at visit 3	6 months
Overall Weight Gain From Visit 1 to Visit 3	the weight gain= the mean weight at visit1 - the mean weight at visit 3	baseline and 6 months

Collaborators and Investigators

• Sponsor: The George Institute for Global Health, China
• Collaborators: Chinese Diabetes Society
• Investigators: Principal Investigator: Linong Ji, Prof., The George Institute for Global Health, China

Publications and helpful links

General Publications

• Luo Y, Wu H, Liao X, Zhao T, Cui N, Li A, Sun X, Zhang P, Huang Y, Zhang X, Yin H, Ji L. A Guideline-Based Decision Tree Achieves Better Glucose Control with Less Hypoglycemia at 3 Months in Chinese Diabetic Patients. Diabetes Ther. 2021 Jul;12(7):1887-1899. doi: 10.1007/s13300-021-01075-1. Epub 2021 May 29.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: diabetes; basal insulin; effectiveness and safety; oral antidiabetic drugs; real world clinical practice
• Other Study ID Numbers: ORBIT