A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients (SIMPLE)

• Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.
  
  

• Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints [ Time Frame: Week 16 and Week 32 ] [ Designated as safety issue: No ]
  Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.
  
  
• Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints [ Time Frame: Week 16 and Week 32 and Week 48 ] [ Designated as safety issue: No ]
  Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 7.0% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 7.4%.
  
  
• Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 6.5% and 7.0% HbA1c are the Japan Diabetes Society (JDS) values, and are equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c values of 6.9% and 7.4%, respectively.
  
  
• Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
  
  
• Change From Baseline in Fasting Glucose at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  
• Change From Baseline in Blood Glucose Profile at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  Time course of changes in blood glucose was determined by 7-point self-monitoring of blood glucose (SMBG) during the day (before breakfast, lunch, and dinner, 2 hours after the start of each meal, and at bedtime).
  
  
• Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  C-peptide is a protein that is produced in the body along with insulin.
  
  
• Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  
• Change From Baseline in Body Weight at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  
• Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48 [ Time Frame: Baseline and Weeks 16, 32 and 48 ] [ Designated as safety issue: No ]
  
• Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48 [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: No ]
  Results are reported as the percentage of participants experiencing hypoglycemia, which was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or they had a blood glucose level below 50 milligram/deciliter (mg/dL) regardless of signs, symptoms or the relationship to treatment.
  
  
• Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48 [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: No ]
  A hypoglycemic episode was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or participants had a blood glucose level below 50 mg/dL regardless of signs, symptoms or the relationship to treatment.
  
  

A multicenter, non-randomized, open-label, post-marketing clinical study. The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs. The study consists of 4 periods: Lead-in Period (2 to 4 weeks), Study Period I (16 weeks), Study Period II (16 weeks), and Study Period III (16 weeks). The regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the HbA1c level. During Study Period I, all the subjects will be given a once daily (QD) injection of lispro mix 50/50. During Study Period II, the regimen of lispro mix 50/50 injection will be changed to twice daily (BID) if the HbA1c level at Week 16 is 6.5% or above, and QD injection will be continued if the value is below 6.5%. During Study Period III, if the HbA1c level at Week 32 is 6.5% or above, the subjects on BID treatment during the previous period (Study Period II) will receive three times daily (TID) injections of insulin.