None listed
Conditions
Interventions
None listed
Sponsors
Sanofi-Aventis Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactChoon Hee Chung
Yonsei University, Wonju Severance Christian Hospital
Outcome results
None listed