N/A
Completed N=18,995
Observational Registry for Basal Insulin Treatment Study (ORBIT)
Source: ClinicalTrials.gov NCT01859598 ↗Enrolled (actual)
18,995
Serious AEs
3.3%
Results posted
Oct 2016
Primary outcomePrimary: To Assess the Change in HbA1c During the 6 Months Follow-up. — 2.1 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Change in HbA1c During the 6 Months Follow-up. |
2.1 | — |
| PRIMARY the Change of Hypoglycemia During Follow-up. |
5.6; 9.6; 9.0 | — |
| SECONDARY the FPG Change From Visit 1 to Visit 3 |
3.8 | — |
| SECONDARY the FPG Control Rate at Visit 3 |
42.5 | — |
| SECONDARY Overall Weight Gain From Visit 1 to Visit 3 |
0.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01859598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.