A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Protamines

Criteria

Inclusion Criteria:

• Diabetes Mellitus, Type 2

• Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)

• Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%

• Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2

• Capable and willing to follow the protocol

• Give written consent

Exclusion Criteria:

• Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)

• Have a history of severe hypoglycemia in the past 6 months

• Are pregnant or may become pregnant

• Women who are breastfeeding

• Have significant cardiac disease

• Have significant renal or liver disease

• Undergoing therapy for a malignancy

• Contraindications to the study medications

• Have an irregular sleep/wake cycle

• Have a serious disease or any condition considered by the investigator to be exclusionary