Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

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 (ILPS) 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.

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: ILPS
  • Insulin Lispro Protamine Suspension (ILPS)
• Active Comparator: Glargine
  • Insulin Glargine

Primary Measures

• Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
  • Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks
    Safety Issue?: No

Secondary Measures

• Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
  • Time Frame: 24 weeks, Endpoint (LOCF) up to 24 weeks
    Safety Issue?: No
• Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
  • Time Frame: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
    Safety Issue?: No
• Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
  • Time Frame: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
    Safety Issue?: No
• 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
  • Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks
    Safety Issue?: No
• Glycemic Variability at Baseline and Endpoint (LOCF)
  • Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks
    Safety Issue?: No
• Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
  • Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks
    Safety Issue?: Yes
• Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
  • Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks
    Safety Issue?: Yes
• Actual Body Weight at Baseline and Endpoint (LOCF)
  • Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks
    Safety Issue?: Yes
• Change From Baseline in Body Weight at Endpoint (LOCF)
  • Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks
    Safety Issue?: Yes
• Total Daily Insulin Dose at Endpoint (LOCF)
  • Time Frame: Endpoint (LOCF) up to 24 weeks
    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 twice a day (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
• Must have a hemoglobin 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 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/NCT00560417

Study ID Number: 11647

ClinicalTrials.gov Identifier: NCT00560417

Health Authority: United States: Food and Drug Administration