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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01067118
• Other study ID #: SU-01292010-4823
• Secondary ID: 17579
• Status: Withdrawn
• Phase: Phase 2
• First received: February 9, 2010
• Last updated: February 9, 2017
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• LINjeta U-100 Insulin
LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors
• Humalog U-100
Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors

Locations

Country	Name	City	State
United States	University of Colorado Denver School of Medicine Barbara Davis Center	Denver	Colorado
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Biodel, University of Colorado Denver School of Medicine Barbara Davis Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal.		2 weeks
Primary	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
Primary	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