Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Lispro Protamine Suspension; Insulin Levemir
Intervention description: Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.; Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Insulin Detemir; Protamines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 387.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; type 1

Summary:

      The purpose of this study is to examine the efficacy and safety of insulin lispro protamine
      suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime
      insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for
      sequentially testing the secondary objectives.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 1 diabetes for one year or more

          -  Age 18 years or older

          -  Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)

          -  Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN)
             reference range within 30 days prior to Visit 1 or collected and analyzed at a local
             laboratory at Visit 1

          -  As determined by the investigator, are capable and willing to do the following:

               -  perform self monitoring of blood glucose (SMBG),

               -  complete patient diaries as required for this protocol,

               -  use the insulin injection device(s) according to the instructions provided,

               -  are receptive to diabetes education,

               -  comply with the required study visits.

        Exclusion Criteria:

          -  Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to
             Visit 1.

          -  Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations
             and Definitions section of the protocol, within 6 months prior to entry into the study

          -  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 or women who are
             breastfeeding

          -  Are receiving chronic (lasting longer than 14 consecutive days) systemic
             glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled
             preparations) or have received such therapy within the 4 weeks immediately preceding
             Visit 1.

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.