Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

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 insulin lispro protamine suspension (ILPS) 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.

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 or twice daily x 24 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Insulin Lispro Protamine Suspension
  • Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
• Active Comparator: Detemir
  • Detemir: Patient specific dose administered subcutaneously once or twice daily 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 Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
  • Time Frame: Baseline, 12 Weeks, 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?: No
• Glycemic Variability
  • 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 for All Study Periods
  • 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
• Number of Injections of Basal Insulin Analog at Endpoint
  • Time Frame: 24 Weeks
    Safety Issue?: No

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 milligrams per day (mg/day);
• Sulfonylureas--1/2 the maximum daily dose, according to the local package insert;
• Dipeptidyl peptidase-intravenous (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 kilograms per square meter (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 milligrams per deciliter (mg/dL) (177 micromoles per liter [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 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/NCT00494013

Study ID Number: 10935

ClinicalTrials.gov Identifier: NCT00494013

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry