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Trial record 1 of 1 for:    NCT01859598
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Observational Registry for Basal Insulin Treatment Study (ORBIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01859598
Recruitment Status : Completed
First Posted : May 22, 2013
Results First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Chinese Diabetes Society
Information provided by (Responsible Party):
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.

Condition or disease

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 19894 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. 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).

  2. 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)

Secondary Outcome Measures :
  1. 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

  2. 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

  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01859598

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China, Beijing
Haidian hospital
Beijing, Beijing, China
Peking University People's Hospital
Beijing, Beijing, China
Sponsors and Collaborators
The George Institute for Global Health, China
Chinese Diabetes Society
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Principal Investigator: Linong Ji, Prof. The George Institute for Global Health, China
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: The George Institute for Global Health, China Identifier: NCT01859598    
Other Study ID Numbers: ORBIT
First Posted: May 22, 2013    Key Record Dates
Results First Posted: October 12, 2016
Last Update Posted: October 12, 2016
Last Verified: February 2016
Keywords provided by The George Institute for Global Health, China:
basal insulin
effectiveness and safety
oral antidiabetic drugs
real world clinical practice