Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Lispro Protamine Suspension; Detemir
Intervention description: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.; Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
Intervention MeSH terms: Insulin Lispro; Protamines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; type 2

Summary:

      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.
    

Eligibility criteria:

        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.