Observational Registry for Basal Insulin Treatment Study (ORBIT)
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|ClinicalTrials.gov Identifier: NCT01859598|
Recruitment Status : Completed
First Posted : May 22, 2013
Results First Posted : October 12, 2016
Last Update Posted : October 12, 2016
|Condition or disease|
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 [Patient Registry]|
|Actual Enrollment :||19894 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
- To Assess the Change in HbA1c During the 6 Months Follow-up. [ Time Frame: Baseline and 6 months ]• Change of HbA1c from baseline to the end-point (6 month).
- the Change of Hypoglycemia During Follow-up. [ Time Frame: baseline and 6 months ]•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)
- the FPG Change From Visit 1 to Visit 3 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline and 6 months ]the weight gain= the mean weight at visit1 - the mean weight at visit 3
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859598
|Beijing, Beijing, China|
|Peking University People's Hospital|
|Beijing, Beijing, China|
|Principal Investigator:||Linong Ji, Prof.||The George Institute for Global Health, China|