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

NCT01067118 | Withdrawn Phase 2 DMC

• 2 other identifiers: SU-01292010-482317579
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Humalog U-100 Insulin

ACTIVE COMPARATOR

Drug: Humalog U-100

LINjeta U-100

EXPERIMENTAL

Drug: LINjeta U-100 Insulin

Interventions

LINjeta U-100 Insulin DRUG

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

Also known as: VIAject U-100

LINjeta U-100

Humalog U-100 DRUG

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

Also known as: Lispro U-100 insulin

Humalog U-100 Insulin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide level and antibody determinations are not needed.

You may not qualify if:

• \) 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.
• \) 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.
• \) 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.
• \) Clinical diagnosis of gastroparesis. 9) Insulin binding capacity greater than 10 microunits per litter

Sponsors & Collaborators

• Stanford University: lead
• Biodel: collaborator
• University of Colorado, Denver: collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Colorado Denver School of Medicine Barbara Davis Center

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bruce A. Buckingham

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 11, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (2)