Observational Registry for Basal Insulin Treatment Study (ORBIT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Change in HbA1c During the 6 Months Follow-up. | • Change of HbA1c from baseline to the end-point (6 month). | 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) | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the FPG Change From Visit 1 to Visit 3 | 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 | 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 | the weight gain= the mean weight at visit1 - the mean weight at visit 3 | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, basal insulin, effectiveness and safety, oral antidiabetic drugs, real world clinical practice