A Randomized, Double-Blind, Crossover Trial Comparing the Safety and Efficacy of Insulin Lispro With the Safety and Efficacy of Insulin Aspart in Subjects With Type 2 Diabetes on CSII Therapy
Overview
- Phase
- Phase 3
- Intervention
- Insulin Lispro
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Eli Lilly and Company
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Glycosylated Hemoglobin A1C (HbA1c) at Endpoint
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.
Detailed Description
This study will provide clinical information on the use of insulin lispro in continuous subcutaneous insulin infusion (CSII) in participants with type 2 diabetes. This study is designed to allow comparison of the 2 rapid-acting insulin analogs, with regard to their efficacy and safety, when used as a pump insulin therapy in this participant population. Each participant will be randomized to 1 of the 2 sequence groups in a 1:1 ratio and randomization will be stratified according to screening A1C (less than or equal to 8.0% or greater than 8.0%) and thiazolidinedione (TZD) use (yes or no). The study design includes the following periods: Screening/Randomization, Treatment Period 1 (16 weeks), and Treatment Period 2 (16 weeks).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have type 2 diabetes (per World Health Organization \[WHO\] Classification of Diabetes)
- •Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months
- •Have a screening A1C less than or equal to 9.0% (no lower limit for A1C)
- •Have a body mass index (BMI) less than 45 kilograms/square meter (kg/m²) at screening
- •Have a history of stable body weight (not varying by greater than 10% for at least 3 months prior to screening)
- •For participants on oral anti-diabetes medications (OAMs): must have been on a stable dose of OAMs, labeled for use with insulin, for at least 3 months prior to study entry
Exclusion Criteria
- •Have severe insulin resistance \[require greater than 2 units/kilogram/day (U/kg/day) of insulin\]
- •Are taking or have taken within the last 3 months, antihyperglycemic medication not approved for use with insulin, injectable non-insulin antihyperglycemic medications, or have a contraindication to current antihyperglycemic medication
- •Have a serum creatinine greater than or equal to 2 milligrams/deciliter (mg/dL) if not on metformin; known metabolic or lactic acidosis; any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study within 48 hours prior to study entry
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intraarticular, and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
- •Have had more than 1 episode of hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
Arms & Interventions
Insulin Lispro, then Insulin Aspart
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Intervention: Insulin Lispro
Insulin Aspart, then Insulin Lispro
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Intervention: Insulin Aspart
Outcomes
Primary Outcomes
Glycosylated Hemoglobin A1C (HbA1c) at Endpoint
Time Frame: After 16 weeks of each treatment (Periods1 and 2)
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (\>8% or ≤8%) and participants.
Secondary Outcomes
- Total Daily Insulin Dose(Week 16 of each treatment (Periods 1 and 2))
- Rate of Hypoglycemic Events Per 30 Days(Baseline through 16 weeks of each treatment (Periods 1 and 2))
- Change From Baseline in Weight(Baseline, Week 16 of treatment Periods 1 and 2)
- Percentage of Participants With Hypoglycemic Events(Baseline through 16 weeks of each treatment (Periods 1 and 2))