To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy

NCT01110746 | Completed Phase 3

• 1 other identifier: VIAject -032J
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 3 hour incremental area under the glucose curve after a standardized high glycemic index meal.

  3 hours

Secondary Outcomes (1)

• Draize scores at insulin infusion site at 24 hour and 72 hour follow-up visits, frequency of discomfort with insulin infusion, and severity of discomfort with insulin infusion (ratings of mild, moderate, or severe).

  72 hours

Study Arms (2)

Formulation A

EXPERIMENTAL

Single Injection

Drug: Viaject 7

Formulation B

EXPERIMENTAL

Single Injection

Drug: LISPRO

Interventions

Viaject 7 DRUG

100IU/mL administered subcutaneously

Formulation A

LISPRO DRUG

100IU/mL administered subcutaneously

Formulation B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females diagnosed with type 1 diabetes mellitus for at least 6 months
• Current usage of subcutaneous insulin pump treatment with one of the following pumps:
• Medtronic Paradigm®
• Animas®
• OmniPod®
• ACCU-CHEK Spirit®
• Age 18-75 years
• HbA1c of 6.0 - 9.0% at screening visit.
• Willingness to attend 9 clinic visits.

You may not qualify if:

• Pregnancy or Lactation
• Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
• Anemia
• Congestive heart failure.
• Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device.
• Active coronary artery disease or heart procedure within the past 4 months.
• Active foot ulceration.
• Severe peripheral arterial disease.
• Stroke within the past 6 months.
• Active alcohol abuse, substance abuse, or severe mental illness.
• Active cancer, except basal cell or squamous cell skin cancers.
• Major surgical operation within 30 days prior to screening.
• Seizure disorder (epilepsy).
• Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
• Currently use of corticosteroids.

Sponsors & Collaborators

• Biodel: lead

Study Sites (1)

Oregon Health and Science University/Legacy Health System

Portland, Oregon, 97232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 27, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 3, 2015

Record last verified: 2015-07

Locations

US (1)