DiabetesNCT01859598

Observational Registry for Basal Insulin Treatment Study (ORBIT)

An observational study of Diabetes, run by The George Institute for Global Health, China at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes
How many people: 19,894 participants
Where: 2 sitesChina
Study dates: Dec 2011to Jun 2014
How long will I take part?: 6 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients meet the following criteria, either from in-patient or out-patient department, will have chance to be enrolled in this study.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

Haidian hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Diabetes
Keywords: diabetes, basal insulin, effectiveness and safety, oral antidiabetic drugs, real world clinical practice
Medical subject headings: Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

To Assess the Change in HbA1c During the 6 Months Follow-up.
- Change of HbA1c from baseline to the end-point (6 month).
Measured: Baseline and 6 months
the Change of Hypoglycemia During Follow-up.
•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)
Measured: baseline and 6 months

Secondary outcomes (3)

the FPG Change From Visit 1 to Visit 3
the FPG change = the FPG level at visit 1- the FPG level at visit 3
Measured: baseline and 6 months
the FPG Control Rate at Visit 3
the percentage of patients who had the FPG level <7.0 mmol/L at visit 3
Measured: 6 months
Overall Weight Gain From Visit 1 to Visit 3
the weight gain= the mean weight at visit1 - the mean weight at visit 3
Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2014

First posted22 May 2013 (estimated)
Study startDec 2011
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 19,894 participants (actual)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT01859598
Sponsor's protocol ID: ORBIT
Status last verified: Feb 2016
First submitted: 13 Apr 2012
Last updated: 12 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Luo Y, Wu H, Liao X, Zhao T, Cui N, Li A, Sun X, Zhang P, Huang Y, Zhang X, Yin H, Ji L. A Guideline-Based Decision Tree Achieves Better Glucose Control with Less Hypoglycemia at 3 Months in Chinese Diabetic Patients. Diabetes Ther. 2021 Jul;12(7):1887-1899. doi: 10.1007/s13300-021-01075-1. Epub 2021 May 29.
PubMed 34050897

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01859598
Acronym / sponsor ID: ORBIT
Conditions: Diabetes
Keywords: diabetes, basal insulin, effectiveness and safety, oral antidiabetic drugs, real world clinical practice
Study type: Observational
Recruitment status: Completed
Enrolment: 19,894 participants (actual)
Lead sponsor: The George Institute for Global Health, ChinaUniversity, hospital or other
Collaborators: Chinese Diabetes Society
Study start: Dec 2011
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 22 May 2013 (estimated)
Results: Posted 12 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 6 Months

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients meet the following criteria, either from in-patient or out-patient department, will have chance to be enrolled in this study.

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

3 secondary outcomes

the FPG Change From Visit 1 to Visit 3
Time frame: baseline and 6 months
the FPG Control Rate at Visit 3
Time frame: 6 months
Overall Weight Gain From Visit 1 to Visit 3
Time frame: baseline and 6 months

Results and safety

Results posted to the registry on 12 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
6-month Follow-up for Basal Insulin Treatment Study (ORBIT)	18,995	17,253

Primary outcome: To Assess the Change in HbA1c During the 6 Months Follow-up.

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: percent

Measure	Basal Insulin Treatment Study (ORBIT) n = 16271
Value	2.1 (2.1)

Population analysed: the patients who have the results of HbA1c

Primary outcome: the Change of Hypoglycemia During Follow-up.

Time frame: baseline and 6 months. Number. Unit: percentage of patients with hypoglycemia

Measure	Follow up for 6 Months n = 16341
Visit 1	5.6
visit 2	9.6
visit 3	9.0

Population analysed: The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Follow up for 6 Months	635 of 18,995 (3.3%)	0 of 18,995 (0%)	Not reported

Limitations and caveats (from the sponsor): The characteristics of patients receiving different treatment modalities may not be consistent, and the use of Basal Insulin (BI) depended on individual choices of doctors and patients, resulting in differences in insulin usage among various regions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34050897Luo Y, Wu H, Liao X, Zhao T, Cui N, Li A, Sun X, Zhang P, Huang Y, Zhang X, Yin H, Ji L. A Guideline-Based Decision Tree Achieves Better Glucose Control with Less Hypoglycemia at 3 Months in Chinese Diabetic Patients. Diabetes Ther. 2021 Jul;12(7):1887-1899. doi: 10.1007/s13300-021-01075-1. Epub 2021 May 29.

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linong Ji, Prof. principal investigator

The George Institute for Global Health, China

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by The George Institute for Global Health, China at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Assess the Change in HbA1c During the 6 Months Follow-up. (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01859598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.