Official Title: “A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide”

This study will compare insulin lispro protamine suspension 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: Insulin Lispro Protamine Suspension
  • Administered subcutaneously once a day at bedtime
• Drug: Insulin Glargine
  • Administered subcutaneously once a day at bedtime

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Insulin Lispro Protamine Suspension
• Active Comparator: 2
  • Insulin Glargine

Primary Measures

• Comparison of change in A1C from baseline after 24 weeks of insulin lispro protamine suspension or insulin glargine
  • Time Frame: Baseline to 24 weeks
    Safety Issue?: No

Secondary Measures

• Comparison of efficacy of two insulin treatments with respect to actual and change from baseline A1C at endpoint and actual A1C at 24 weeks
  • Time Frame: Baseline, endpoint and 24 weeks
    Safety Issue?: No
• Comparison of efficacy of two insulin treatments with respect to percentage of subjects with A1C less than 7.0% and A1C less than or equal to 6.5%
  • Time Frame: Weeks 12, 18, 24 and endpoint
    Safety Issue?: No
• Comparison of efficacy of two insulin treatments with respect to seven point blood glucose profiles and glycemic variability
  • Time Frame: Baseline and endpoint
    Safety Issue?: No
• Comparison of safety as measured by: the incidence and rate of self-reported hypoglycemic episodes, actual and change of body weight, treatment-emergent adverse events
  • Time Frame: Throughout study and endpoint
    Safety Issue?: Yes
• Insulin dose at endpoint
  • Time Frame: Endpoint
    Safety Issue?: No

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 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 or 4 mg/day rosiglitazone
• Must have an 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 74 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

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  

Overall Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00560417

Study ID Number: 11647

ClinicalTrials.gov Identifier: NCT00560417

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry