Lispro Mix 25 vs. Glargine in Type 2 Diabetics

Condition(s) targeted: Diabetes Mellitus Type 2

Intervention: Insulin lispro mix 25 (Drug); Glargine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast

Secondary outcome:

Hemoglobin A1c measured at endpoint

Change of hemoglobin A1c from baseline to endpoint

Glycemic control as determined by self-monitored blood glucose concentrations

The incidence and rate of self-reported hypoglycemic episodes

Body mass index (BMI)

Body weight

Total Insulin Doses

Detailed 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.

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mexico City, Mexico

Lilly Clinical Trial Registry

Starting date: November 2002
Last updated: October 29, 2007