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A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.
Not Recruiting
Trial ID: NCT01067118
Purpose
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.
Official Title
Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia
Stanford Investigator(s)
Bruce Buckingham
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
Eligibility
Inclusion Criteria:1)Type 1 diabetes for at least 1 year
1. The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide
level and antibody determinations are not needed.
2) Age : 18 years old ¨C 49.99 years old 3) Continuous subcutaneous insulin infusion
(CSII) therapy for at least 3 months 4) Participant consent demonstrated by signing
IRB approved documents 6) HgA1c ¡Ü 9% 7) If participant is female with reproductive
potential, willing to avoid pregnancy and pregnancy test negative. Exclusion
Criteria:1) Chronic oral steroid use
2) The presence of a significant medical disorder that in the judgment of the
investigator will affect the wearing of sensors or the completion of any aspect of the
protocol.
3) Known clinical history of celiac disease or inflammatory bowel disease. 4)
Participants will have a negative anti-endomysial antibody or anti-tissue
transglutaminase antibody within one year of enrollment.
5) Cystic Fibrosis 6) Inpatient psychiatric treatment in the past 6 months. 7)
Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
8) Clinical diagnosis of gastroparesis. 9) Insulin binding capacity greater than 10
microunits per litter
Intervention(s):
drug: LINjeta U-100 Insulin
drug: Humalog U-100
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Parul Patel
6507235791