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

Lilly

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin glargine

Drug: Insulin lispro mid mixture (MM)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00377858

F3Z-MC-IOOX

10936 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

484 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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