Clinical trial NCT01859598: Observational Registry for Basal Insulin Treatment Study (ORBIT)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: diabetes
basal insulin
effectiveness and safety
oral antidiabetic drugs
real world clinical practice
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: Chinese Diabetes Society
First posted: 2013-05-22
Enrollment: 19894
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: To Assess the Change in HbA1c During the 6 Months Follow-up.
timeFrame: Baseline and 6 months
measure: the Change of Hypoglycemia During Follow-up.
timeFrame: baseline and 6 months
Secondary outcomes:
measure: the FPG Change From Visit 1 to Visit 3
timeFrame: baseline and 6 months
measure: the FPG Control Rate at Visit 3
timeFrame: 6 months
measure: Overall Weight Gain From Visit 1 to Visit 3
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Haidian hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: The George Institute for Global Health, China
name: Linong Ji, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.