The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.

This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.

The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Biphasic Insulins; Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, insulin lispro drug combination 50:50

Criteria

Inclusion Criteria:

• Must have type 2 diabetes.

• Must be at least 30 and less than 80 years of age at the time of Visit 1.

• Must be on at least two oral antidiabetes medications for at least 90 days.

• Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

Exclusion Criteria:

• Must not have used insulin on a regular basis in the last 12 months.

• Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.

• Must not have a body mass index (BMI) of greater than 45 (morbid obesity).

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

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