Lispro Mix 25 vs. Glargine in Type 2 Diabetics (IOOL)

Lilly

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: Insulin lispro mix 25

Drug: Glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00551356

7354

F3Z-ME-IOOL

Details and patient eligibility

About

In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.

Full description

The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

Enrollment

53 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females who have type 2 diabetes between 1 and 10 years
Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
Have not been on insulin treatment within 3 months before entry into the study
Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
Have a body mass index below 40 kg/m²

Exclusion criteria

Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
Have a known allergy to insulin
Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
Have known proliferative retinopathy
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study