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

Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia

Sponsors

Lead Sponsor: Stanford University

Collaborator: Biodel
University of Colorado Denver School of Medicine Barbara Davis Center

Source Stanford University
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.

Overall Status Withdrawn
Start Date April 2010
Completion Date June 2011
Primary Completion Date January 2011
Phase Phase 2
Study Type Interventional
Primary Outcome
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
Condition
Intervention

Intervention Type: Drug

Intervention Name: LINjeta U-100 Insulin

Description: LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors

Arm Group Label: LINjeta U-100

Other Name: VIAject U-100

Intervention Type: Drug

Intervention Name: Humalog U-100

Description: Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors

Arm Group Label: Humalog U-100 Insulin

Other Name: Lispro U-100 insulin

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bruce A. Buckingham Principal Investigator Stanford University
Location
Facility:
Stanford University School of Medicine | Stanford, California, 94305, United States
University of Colorado Denver School of Medicine Barbara Davis Center | Denver, Colorado, 80045, United States
Location Countries

United States

Verification Date

February 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Stanford University

Investigator Full Name: Bruce A. Buckingham

Investigator Title: Principle Investigator

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Humalog U-100 Insulin

Type: Active Comparator

Label: LINjeta U-100

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov