A Study for Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2605541; Insulin glargine
Intervention description: Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.; Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.
Intervention MeSH terms: Insulin Glargine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new
      basal insulin analog and when they take insulin glargine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes mellitus (T1DM) for at least 1 year and using insulin glargine for at
             least 6 months with a maximum daily dose of 1 unit per kilogram (U/kg).

          -  Hemoglobin A1c (HbA1c) of no greater than 10.5% before randomization

          -  Body mass index (BMI) 19 to 45 kilogram per square meter (kg/m²)

          -  Capable and willing to prepare and inject insulin with a syringe, monitor own blood
             glucose, complete the study diary, be receptive to diabetes education, comply with
             study requirements, and receive telephone calls during treatment

          -  Women of childbearing potential must test negative for pregnancy before receiving
             treatment and agree to use reliable birth control until completing the follow-up

        Exclusion Criteria:

          -  Twice daily use of insulin glargine within 30 days prior to the study

          -  Use of any oral or injectable medication intended for the treatment of diabetes
             mellitus other than insulins in the 3 months prior to the study

          -  Use of an insulin pump

          -  More than 1 episode of severe hypoglycemia within 3 months prior to the study, or
             currently diagnosed as having hypoglycemia unawareness

          -  2 or more emergency room visits or hospitalizations due to poor glucose control in the
             6 months preceding the study

          -  Known hypersensitivity or allergy to any of the study insulins or their excipients

          -  Blood transfusion or severe blood loss within 3 months prior to the study or known
             hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of
             hemoglobin abnormalities known to interfere with the HbA1c methodology

          -  Irregular sleep/wake cycle

          -  Pregnant or intend to become pregnant during the study

          -  Women who are breastfeeding

          -  Use of prescription or over-the-counter medications to promote weight loss within 3
             months prior to the study

          -  Current participation in a weight loss program or plans to do so during the study

          -  Use of chronic (lasting longer than 14 consecutive days) systemic glucocorticoid
             therapy currently or within 4 weeks prior to the study

          -  Cardiac disease with a marked impact on physical functioning

          -  Clinically significant electrocardiogram (ECG) abnormalities at screening

          -  Fasting triglycerides greater than 500 milligram per deciliter (mg/dL)

          -  Liver disease

          -  History of renal transplantation, current renal dialysis, or creatinine greater than
             2.0 mg/dL (177 micromole per liter [μmol/L])

          -  Malignancy other than basal cell or squamous cell skin cancer, currently or within the
             last 5 years

          -  Treatment with any antibody-based therapy within 6 months prior to the study