Efficacy of Insulin Lispro Mix 50/50 Therapy

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device. The management is comparatively simple and easy, but the curative effect is promising. It is also reported that noninferiority has been observed between basal/bolus therapy (BBT) and prandial premixed therapy (PPT, lispro mix 50/50 t.i.d.).

The purpose of this study is to evaluate whether change of insulin therapy from BBT (long-acting insulin at bedtime plus mealtime rapid-acting insulin) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) to lispro mix 50/50 t.i.d. improves glycemic control of patients with type 2 diabetes mellitus.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aichi Gakuin University
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Isophane insulin, insulin lispro drug combination 50:50

Criteria

Inclusion Criteria:

Type 2 diabetes patients who are treated with insulin basal/bolus therapy ( long-acting insulin at bedtime and mealtime rapid-acting insulin ) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) and whose HbA1c is above 7.4%.

Exclusion Criteria:

• Patients with renal failure with serum creatinine level ≧ 2.0

• Patients with hepatocirrhosis

• Patients with proliferative diabetic retinopathy or worse

• Patients with acute infectious disease

• Patients who are treated with steroids

• Patients with cancer

• Pregnant patients

• Patients who are decided to be inappropriate subjects by study physicians