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

Official Title: “Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections”

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.

Intervention(s) in this Clinical Trial

• Drug: Insulin lispro mid mixture (MM)
  • Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
• Drug: Insulin glargine
  • Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Insulin Lispro Mid Mixture
  • Insulin lispro mid mixture (MM) up to three times a day (TID)
• Active Comparator: Insulin Glargine
  • Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Primary Measures

• Hemoglobin A1c (HbA1c) at 36 Week Endpoint
  • Time Frame: 36 weeks
    Safety Issue?: No

Secondary Measures

• Hemoglobin A1c (HbA1c) at Interval Visits
  • Time Frame: 12, 24, and 36 weeks
    Safety Issue?: No
• Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
  • Time Frame: 12-24-36 weeks
    Safety Issue?: No
• 7-point Self-monitored Blood Glucose Profiles
  • Time Frame: Baseline, 12-24-36 weeks
    Safety Issue?: No
• Glycemic Variability
  • Time Frame: Baseline, 12-24-36 weeks
    Safety Issue?: No
• Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
  • Time Frame: Baseline to 36 Weeks
    Safety Issue?: Yes
• 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
  • Time Frame: Baseline to 36 Weeks
    Safety Issue?: Yes
• Number of Patients With at Least One Severe Hypoglycemia Episode
  • Time Frame: Baseline to 36 Weeks
    Safety Issue?: Yes
• Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
  • Time Frame: 36 Weeks
    Safety Issue?: No
• Endpoint Insulin Dose; Total, Basal, and Prandial
  • Time Frame: 36 Weeks
    Safety Issue?: No
• Number of Insulin Injections Per Day
  • Time Frame: Weeks 12, 24, 30, 36
    Safety Issue?: No
• Change From Baseline in Absolute Body Weight at 36 Week Endpoint
  • Time Frame: Baseline, 36 Weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00377858

Study ID Number: 10936

ClinicalTrials.gov Identifier: NCT00377858

Health Authority: United States: Institutional Review Board

Lilly Clinical Trial Registry