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

Lilly

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin Lispro Protamine Suspension

Drug: Insulin Glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00560417

11647

F3Z-US-IOPB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

339 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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