Observational Registry for Basal Insulin Treatment Study (ORBIT)

August 17, 2016 updated by: The George Institute for Global Health, China

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19894

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking University People's Hospital
      • Beijing, Beijing, China
        • Haidian hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 6 months
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)
baseline and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline and 6 months
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
6 months
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
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The George Institute for Global Health, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese Diabetes Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linong Ji, Prof., The George Institute for Global Health, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORBIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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