Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01474538
- Lead Sponsor
- Eli Lilly and Company
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Insulin Aspart, then Insulin Lispro Insulin Aspart 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. Insulin Lispro, then Insulin Aspart Insulin Lispro 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.
- Primary Outcome Measures
Name Time Method Glycosylated Hemoglobin A1C (HbA1c) at Endpoint 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 Outcome Measures
Name Time Method Total Daily Insulin Dose Week 16 of each treatment (Periods 1 and 2) Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (\>8% or ≤8%) and participants.
Rate of Hypoglycemic Events Per 30 Days Baseline through 16 weeks of each treatment (Periods 1 and 2) A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (\>8% or ≤8%).
Change From Baseline in Weight Baseline, Week 16 of treatment Periods 1 and 2 Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (\>8% or ≤8%), baseline weight and participants.
Percentage of Participants With Hypoglycemic Events Baseline through 16 weeks of each treatment (Periods 1 and 2) A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Salt Lake City, Utah, United States