Observational Registry for Basal Insulin Treatment Study (ORBIT)

Completed

• Conditions: Diabetes

• Registration Number: NCT01859598
• Lead Sponsor: The George Institute for Global Health, China

Brief Summary

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.

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-02
• Results First Submitted: 2016-02-15
• Results First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Results First Posted: 2016-10-12
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19894

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Haidian hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China