Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

Eli Lilly and Company122 enrolled

Overview

This study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

122

Conditions

Type 2 Diabetes Mellitus

Interventions

Insulin LisproDRUG

Insulin lispro (100 U/mL) administered by CSII pump

Insulin AspartDRUG

Insulin aspart (100 U/mL) administered by CSII pump

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (12)

Outcomes

Primary Outcomes

Glycosylated Hemoglobin A1C (HbA1c) at Endpoint

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.

Time frame: After 16 weeks of each treatment (Periods1 and 2)

Secondary Outcomes

Total Daily Insulin Dose

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.

Time frame: Week 16 of each treatment (Periods 1 and 2)

Rate of Hypoglycemic Events Per 30 Days

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%).

Time frame: Baseline through 16 weeks of each treatment (Periods 1 and 2)

Change From Baseline in Weight

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.

Time frame: Baseline, Week 16 of treatment Periods 1 and 2

Percentage of Participants With Hypoglycemic Events

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.

Data from ClinicalTrials.gov

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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.

Little Rock, Arkansas, United States

Jacksonville, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Idaho Falls, Idaho, United States

Des Moines, Iowa, United States

Topeka, Kansas, United States

Metairie, Louisiana, United States

Asheville, North Carolina, United States

Chattanooga, Tennessee, United States

...and 2 more locations