Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

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

Details

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

Criteria

Inclusion Criteria:

• Must have type 2 diabetes

• Must be at least 18 years of age and less than 75 years of age

• Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months

• Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone

• Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria:

• Must not have used insulin on a regular basis during the past 2 years

• Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months

• Must not have had more than one episode of severe hypoglycemia in the past 6 months

• Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease

• Must not be pregnant or intend to get pregnant during the course of the study