Observational Registry for Basal Insulin Treatment Study (ORBIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The George Institute for Global Health, China
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: May 20, 2013
Last verified: May 2013
  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: 6 month ] [ Designated as safety issue: No ]
    • Change of HbA1c from baseline to the end-point (6 month).
    • Percentage of patients reaching the target of HbA1c <7.0% at the end-point.

  • To assess the change in frequency of hypoglycemia and other adverse events during the 6 months follow-up. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • The number of severe adverse events during the 6 months follow-up.
    • Change of cumulative number of severe hypoglycaemic episodes during 3 months before baseline and the end-point.
    • Change of cumulative number of hypoglycaemic episodes during 1 month before baseline and the end-point.
    • Change of body weight from baseline to the end-point.


Secondary Outcome Measures:
  • Compare the HbA1c change during the follow-up among the commonly used basal insulins (NPH, Glargine and Detemir insulin) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Compare the HbA1c change and HbA1c control rate among the three commonly used basal insulins.

  • Compare the incidence of adverse events during the follow-up among the commonly used basal insulins (NPH, Glargine and Detemir insulin) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Compare the following indicators among the three commonly used basal insulins:

    • The number of severe adverse events during the 6 months follow-up.
    • Change of cumulative number of severe hypoglycaemic episodes during 3 months before baseline and the end-point.
    • Change of cumulative number of hypoglycaemic episodes during 1 month before baseline and the end-point.
    • Change of body weight from baseline to the end-point.

  • To explore the factors that influence the glycemic control and safety of basal insulin regimens [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    To explore the influence factors of HbA1c control and adverse events by univariate and multivariate analysis.

    • Dependent variables: change in HbA1c, hypoglycemia and body weight
    • Independent/categorical variables: regions, level of hospital, glycemic level at baseline, type of basal insulin at baseline, dose of insulin at the endpoint, combination therapy, self monitoring of blood glucose, lifestyle, cost of drug, etc
    • Covariates: demographic characteristic

  • To explore the impact of BI regimens to the quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To describe and compare the change in quality of life before and after initial basal insulin regimens


Estimated Enrollment: 20000
Study Start Date: December 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 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
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

Contacts
Contact: Puhong Zhang, PhD +86 10 8280 0476-512 zpuhong@georgeinstitute.org.cn
Contact: Yangfeng Wu +86 10 8280 0577

Locations
China, Beijing
Haidian hospital Recruiting
Beijing, Beijing, China
Contact: Wei Huang    +86-10-82619999      
Peking University People's Hospital Recruiting
Beijing, Beijing, China
Contact: Linong Ji    +86-10-66515716      
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

No publications provided

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
Last Updated: May 20, 2013
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:
Hypoglycemic Agents
Insulin
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014