Official Title: “Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus”

The purpose of this study is to examine the effectiveness and safety of lispro suspension as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

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 specific dose administered subcutaneously once daily or twice daily x 24 weeks.
• Drug: Detemir
  • Patient specific dose administered subcutaneously once daily x 24 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Insulin Lispro Protamine Suspension
• Active Comparator: 2
  • Detemir

Primary Measures

• Change in Hemoglobin A1c.
  • Time Frame: Baseline to twenty four weeks
    Safety Issue?: Yes

Secondary Measures

• Actual and change from baseline HbA1c value at 12 weeks and at endpoint
  • Time Frame: 12-24 weeks
    Safety Issue?: No
• Percentage of patients with HbA1c <7.0% and HbA1c < or = 6.5% at endpoint
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• 7-point self-monitored blood glucose (SMBG) profile at endpoint
  • Time Frame: 24 weeks
    Safety Issue?: No
• Glycemic variability at endpoint
  • 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 hypoglycemic episodes (throughout the study and at endpoint), including nocturnal and non-nocturnal; and severe hypoglycemia
  • Time Frame: Visits 3, 4, 5, 6, 7, 8, 9, Early Term
    Safety Issue?: Yes
• Absolute body weight (kg) and incremental weight change from baseline to endpoint
  • Time Frame: Every office visit, Early Term
    Safety Issue?: Yes
• Treatment-emergent adverse events (TEAEs)
  • Time Frame: Every visit
    Safety Issue?: Yes
• Total daily insulin dose at endpoint
  • Time Frame: 24 weeks
    Safety Issue?: No
• Number of injections of basal insulin analog at endpoint
  • Time Frame: 24 weeks
    Safety Issue?: No
• Intrapatient glycemic variability as measured from self-monitored blood glucose (SMBG) profiles at 24 weeks
  • Time Frame: 24 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Have type 2 diabetes mellitus for at least 1 year.
• 2. Are at least 18 years old.
• 3. 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, at or above the doses defined in the following: Metformin--1500 mg/day; Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-IV (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert;
• Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
• 4. 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. 5.Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m2.

Exclusion Criteria

• 1. 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.
• 2. 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.
• 3. 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.
• 4. Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 mg/dL (177 micromol/L).
• 5. Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00494013

Study ID Number: 10935

ClinicalTrials.gov Identifier: NCT00494013

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry