Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DRUGLINjeta U-100 Insulin
LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors
DRUGHumalog U-100
Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors
Sponsors
Biodel
University of Colorado, Denver
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal. | 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. | 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. | 6 weeks |
Countries
United States
Outcome results
None listed