The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors
Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors
Stanford University School of Medicine
Stanford, California, United States
University of Colorado Denver School of Medicine Barbara Davis Center
Denver, Colorado, United States
The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal.
Time frame: 2 weeks
The primary endpoint for this second phase is the 3 hour area under the curve from baseline following a standardized breakfast meal in the outpatient setting.
Time frame: 2 weeks
The primary endpoint for this third phase is daytime (6 am to midnight) average glucose values.is percent of CGMS glucose values in range (70-180 mg/dL) for the third week fo sensor data in each group.
Time frame: 6 weeks
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