Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Observational Registry for Basal Insulin Treatment Study (ORBIT)

This study has been completed.
Sponsor:
Collaborator:
Chinese Diabetes Society
Information provided by (Responsible Party):
The George Institute for Global Health, China
ClinicalTrials.gov Identifier:
NCT01859598
First received: April 13, 2012
Last updated: August 17, 2016
Last verified: February 2016
  Purpose
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
Diabetes

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The George Institute for Global Health, China:

Primary Outcome Measures:
  • To Assess the Change in HbA1c During the 6 Months Follow-up. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    • Change of HbA1c from baseline to the end-point (6 month).

  • the Change of Hypoglycemia During Follow-up. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
    •The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)


Secondary Outcome Measures:
  • the FPG Change From Visit 1 to Visit 3 [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    the weight gain= the mean weight at visit1 - the mean weight at visit 3


Enrollment: 19894
Study Start Date: December 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859598

Locations
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
Investigators
Principal Investigator: Linong Ji, Prof. The George Institute for Global Health, China
  More Information

Responsible Party: The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT01859598     History of Changes
Other Study ID Numbers: ORBIT 
Study First Received: April 13, 2012
Results First Received: February 15, 2016
Last Updated: August 17, 2016
Health Authority: China: Ethics Committee

Keywords provided by The George Institute for Global Health, China:
diabetes
basal insulin
effectiveness and safety
oral antidiabetic drugs
real world clinical practice

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 08, 2016