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

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01110746

Run by

Biodel

People needed

20

Starts

2010-02-01

Expected to finish

2010-06-01

Last updated by the study team

2015-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• History of major non-compliance.
• Use of an investigational drug within 30 days prior to screening.
• Bleeding disorder, treatment with warfarin, or low platelet count.
• Any insulin allergy
• Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema.
• History of gastroparesis.

Where it is running

• Oregon Health and Science University/Legacy Health System — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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