A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.

Not Recruiting

Trial ID: NCT01067118


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
Bruce Buckingham

Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus


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

   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


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