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

This study has suspended participant recruitment.
(The study was suspended due to lack of study drug)
Sponsor:
Collaborators:
Biodel
University of Colorado Denver School of Medicine Barbara Davis Center
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01067118
First received: February 9, 2010
Last updated: January 31, 2011
Last verified: January 2011
History of Changes
  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.


Condition Intervention Phase
Diabetes Mellitus
 Drug: LINjeta U-100 Insulin
Drug: Humalog U-100
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Humalog U-100 Insulin Drug: Humalog U-100
Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors
Other Name: Lispro U-100 insulin
Experimental: LINjeta U-100 Drug: LINjeta U-100 Insulin
LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors
Other Name: VIAject U-100

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067118

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Denver School of Medicine Barbara Davis Center
Denver, Colorado, United States, 80045
Sponsors and Collaborators
Stanford University
Biodel
University of Colorado Denver School of Medicine Barbara Davis Center
Investigators
Principal Investigator: Bruce A. Buckingham Stanford University
  More Information

No publications provided

Responsible Party: Bruce A. Buckingham, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01067118     History of Changes
Other Study ID Numbers: SU-01292010-4823, 17579
Study First Received: February 9, 2010
Last Updated: January 31, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013