BART: Benefits of Adding Rapid-acting insulin(s) in patients with diabetes currently uncontrolled on basal insulin Therapy: A prospective observational study in Korea.

Not Applicable

Completed

Conditions: Endocrine, nutritional and metabolic disease

Registration Number: KCT0005689

Lead Sponsor: Sanofi-Aventis Korea

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 242

Inclusion Criteria

1) Type 2 DM patients who have received basal insulin treatment at least for 3 months irrespective of combined use of oral hypoglycemic agent
2) Patients who had more than 7% in glycosylated hemoglobin (HbA1c) within 3 months following involvement
3) Patients who had 70=FBG=150mg/dl and PP2BG=180mg/dl of blood glucose levels measured with self-monitoring blood glucose system within 2 weeks following involvement
4) Patients who were planned to add rapid acting insulin to basal insulin
5) Patients who might receive basal insulin during the study period
6) Male and female adults aged more than 20 years
7) Patients who signed the personal information use consent form prior to involvement

Exclusion Criteria

1) Patients who did not have type 2 diabetes
2) Patients who were being involved in clinical studies using drug
3) Patients who have used other insulin product other than basal insulin within recent 3 months (with the exception of temporary insulin dosing in an emergency)
4) Patients who are not eligible for enrollment in physician’s judgment

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in glycosylated hemoglobin(HbA1c) after adding rapid-acting insulin(s) to uncontrolled T2DM patients who are currently on basal insulin therapy(irrespective of combination with OHA).

Secondary Outcome Measures

Name	Time	Method
1)Percentage of patients achieving target glycosylated hemoglobin(<7%) 2) Percentage of patients achieving target postprandial glucose(<180mg/dL) 3) Percentage of patients achieving target fasting blood glucose(<130mg/dL) 4) Change of fasting blood glucose and postprandial glucose 5) Dose change of rapid acting insulin and combination therapy 6) Change of BMI, weight, and lipid profile 7) Dosing time of basal insulin and rapid acting insulin 8) Reasons for failure in achieving the goal specified in the ADA guideline and reasons for dissatisfaction with prescribed basal insulin and rapid acting insulin in physician’s judgment