Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes

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.

Phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ILPS, also referred to as NPL [neutral protamine Hagedorn]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.

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.