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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin Lispro; Isophane insulin, insulin lispro drug combination 50:50

Criteria

Inclusion Criteria:

• Patients diagnosed as having type 2 Diabetes.

• Patients who have not been on insulin treatment within 6 months.

• Patients who have been taking OADs for at least 90 days.

• Patients with an HbA1c level in the range of 7.5% to 11.0%.

• Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.

Exclusion Criteria:

• Patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).

• Patients having or suspected of having malignancy

• Patients having serious complications of the heart, liver, or kidney.

• Patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.

• Patients receiving systemic steroids.

• Are currently enrolled in a clinical trial of a non-approved drug. Or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.

• Patients of child-bearing potential. Breastfeeding patients. Patients with a positive result in a pregnancy test performed for women of child-bearing potential.