OHSU

IRB #

IRB00009818

Title

Efficacy and Safety of FIAsp compared to insulin aspart both in Combination with insulin detemir in Adults with Type 1 Diabetes. Onset 1

Principal Investigator

Andrew Ahmann

Study Purpose

The purpose of this study is to evaluate the safety and effectiveness of an unapporoved drug, FIAsp (Fasting Acting Insulin Aspart) compared to insulin aspart, a drug that is approved by the FDA to treat Type 1 Diabetes when used with long acting insulin detemir.

Medical Condition(s)

Type 1 Diabetes

Eligibility Criteria

Female or male, between 18-80 years old
Type 1 diabetes (diagnosed clinically) greater than 12 months at time of screening
Currently treated with basal-bolus insulin regimen for at least 12 months
Currently treated with a basal insulin analogue (any regimen of insulin detemir or glargine) for at least 4 months
HbA1c between 7.0-9.5%
Body Mass Index less than 35.0 kg/m
Ability and willingness to eat at least 3 meals (breakfast, lunch, dinner) every day during trial

Age Range

18 - 80

Healthy Volunteers Needed

No

Duration of Participation

The entire study will take approximately 66 weeks to complete

Minors Included

No

Contact

Harold Schnitzer Diabetes Health Center Reseach Department
503-494-4704

Sponsor

Novo Nordisk

Recruitment End

06/30/2014

Compensation Provided

Yes

Compensation

Total Compensation Amount: Up to $1790
$50 per completed clinic visit
$20 per completed phone visit


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