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

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ClinicalTrials.gov Identifier: NCT01067118
Recruitment Status : Withdrawn (The study was suspended due to lack of study drug)
First Posted : February 11, 2010
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: LINjeta U-100 Insulin Drug: Humalog U-100 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Study Start Date : April 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bruce A. Buckingham, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01067118     History of Changes
Other Study ID Numbers: SU-01292010-4823
17579
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs