Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Have type 2 diabetes

• Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label

• Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Exclusion Criteria:

• Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.

• Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.

• Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.

• Have a body mass index greater than 40 kg/m2.

• Have had more than one episode of severe hypoglycemia in the last24 weeks

• Are pregnant, intend to be pregnant during the course of the study or are breastfeeding

• Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease