Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)

Official Title: “The PERSISTENT Trial: A Prospective Randomized Trial Comparing Insulin Lispro Protamine Suspension to Insulin Glargine in Patients With Type 2 Diabetes on Anti-hyperglycemic Medications”

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.

Intervention(s) in this Clinical Trial

• Drug: Insulin Lispro Protamine Suspension
  • Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
• Drug: Insulin Glargine
  • Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Lispro
  • Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
• Active Comparator: Glargine
  • Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks

Primary Measures

• Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
  • Time Frame: Baseline, 24 Weeks
    Safety Issue?: No

Secondary Measures

• Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
  • Time Frame: Baseline, 12 Weeks, 24 Weeks
    Safety Issue?: No
• Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint
  • Time Frame: 24 weeks
    Safety Issue?: No
• Glycemic Variability at Endpoint
  • Time Frame: 24 weeks
    Safety Issue?: No
• 7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
  • Time Frame: 24 weeks
    Safety Issue?: No
• Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall
  • Time Frame: Baseline to 24 weeks
    Safety Issue?: Yes
• 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
  • Time Frame: Baseline to 24 weeks
    Safety Issue?: Yes
• 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
  • Time Frame: Baseline to 24 Weeks
    Safety Issue?: Yes
• Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
  • Time Frame: Baseline, 24 weeks
    Safety Issue?: Yes
• Total Daily Insulin Dose (Units) at Endpoint
  • Time Frame: 24 weeks
    Safety Issue?: No
• Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
  • Time Frame: 24 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Have type 2 diabetes mellitus for at least 1 year.
• Are greater than or equal to 18 years old.
• Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin-
• Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)
• Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
• Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.

Exclusion Criteria:

• Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
• Have taken any glucose-lowering medications not included in Inclusion Criterion #3;
• (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
• Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
• Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
• Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

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/NCT00510952

Study ID Number: 11813

ClinicalTrials.gov Identifier: NCT00510952

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry