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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Insulin Lispro Protamine Suspension
  • Administered subcutaneously once daily.
• Drug: Detemir
  • Administered subcutaneously once daily.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Change in Hemoglobin A1c.
  • Time Frame: Baseline to twenty four weeks
    

Secondary Measures

• Measurement of intrapatient glycemic variability.
  • Time Frame: Measured at 24 weeks.
    
• Change in body weight.
  • Time Frame: Baseline to 24 weeks.
    

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 September 05, 2008

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