Status:

COMPLETED

Observational Registry for Basal Insulin Treatment Study (ORBIT)

Lead Sponsor:

The George Institute for Global Health, China

Collaborating Sponsors:

Chinese Diabetes Society

Conditions:

Diabetes

Eligibility:

All Genders

18-80 years

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 ...

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 diabete...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

19894 Patients enrolled

Trial Details

Trial ID

NCT01859598

Start Date

December 1 2011

End Date

June 1 2014

Last Update

October 12 2016

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Haidian hospital

Beijing, Beijing Municipality, China

2

Peking University People's Hospital

Beijing, Beijing Municipality, China