Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes

Lilly

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Glargine Basal-Bolus Therapy

Drug: Lispro Mixture Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00110370

9057

F3Z-US-IOOQ

Details and patient eligibility

About

The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must have type 2 diabetes.
Must be 30-75 years of age at the time of Visit 1.
Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
Must be on at least 30 units of glargine per day at enrollment.
Have an A1C between 7.5% and 12.0% at Visit 1.

Exclusion criteria

Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
Must not have more than one episode of severe hypoglycemia in the last 6 months.
Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
Must not have congestive heart failure that requires medications.
Must not have had a kidney transplant or currently receiving dialysis