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 as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Insulin Lispro Protamine Suspension
  • Patient adjusted dose, QD or BID, injected SC x 24 weeks
• Drug: Insulin Glargine
  • Patient adjusted dose, QD, injected SC x 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Insulin Lispro protamine suspension
• Active Comparator: 2
  • Insulin glargine

Primary Measures

• Change in Hemoglobin A1c
  • Time Frame: 24 weeks
    Safety Issue?: Yes

Secondary Measures

• Actual and change from baseline HbAlc value.
  • Time Frame: 12-24 weeks
    Safety Issue?: Yes
• 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
• 7-point self-monitored blood glucose (SMBG) profile
  • Time Frame: 24 weeks
    Safety Issue?: No
• The incidence, rate (30-day and 1-year adjusted), and percent reduction (for incidence and rate) of self-reported hypoglycemic episodes (throughout the study and at endpoint), including nocturnal and non-nocturnal
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• Absolute body weight (kg) and incremental weight change
  • Time Frame: 24 weeks
    Safety Issue?: No
• Treatment-emergent adverse events (TEAEs).
  • Time Frame: Every visit
    Safety Issue?: Yes
• Total daily insulin dose.
  • Time Frame: 24 weeks
    Safety Issue?: No
• Incidence, rate (30-day and 1-year adjusted), and percent reduction (for incidence and rate) of self-reported severe hypoglycemia episodes
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• Glycemic variability
  • Time Frame: 24 weeks
    Safety Issue?: Yes

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 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  

Information obtained from ClinicalTrials.gov on October 10, 2008

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