The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.
The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
SC injection, once-daily, given in conjunction with oral antidiabetic medications.
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States
Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
Time frame: At end of treatment arm or 3 months.
HbA1c
Time frame: At end of treatment arm or 3 months.
2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined
Time frame: At end of treatment arm or 3 months.
Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL)
Time frame: At end of treatment arm or 3 months.
The number of patients with increased plasma glucose during the last 2 hours of each inpatient period
Time frame: At end of treatment arm or 3 months.
The mean amplitude of glycemic excursion
Time frame: At end of treatment arm or 3 months.
Concentration of plasma triglycerides and free fatty acids
Time frame: At end of treatment arm or 3 months.
Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value
Time frame: At end of treatment arm or 3 months.
Insulin dose and body weight
Time frame: At end of treatment arm or 3 months.
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