Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus
Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes
 (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch
 on insulin delivery device) to control his/her blood glucose.
This is a single center, open label, feasibility of use and performance evaluation of PaQ™
 (using insulin aspart) in patients with T2DM who are currently receiving basal/bolus insulin
 therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's
 participation in the study is comprised of four phases: screening, baseline evaluation,
 transition to PaQ™ use, and PaQ™ treatment period. The use of these phases will allow an
 orderly transition to PaQ™ treatment as well as a reliable construct from which to interpret
 the final data.
Inclusion Criteria:

 1. Male/female patient's ≥ 30 ≤ 65 years of age.

 2. Clinical confirmation of T2DM diagnosis by history and medication usage or glucose
 tolerance test.

 3. Currently treated with insulin using a basal/bolus regimen with or without concurrent
 use of OADs (metformin and/or glitazone).

 4. Currently on a stable insulin regimen "as judged by the investigator" (using an
 estimate of their basal dose of insulin does not fluctuate by more than ±10% every
 day) and if he/she is receiving a concurrent oral agent, the dose has remained
 unchanged for the last 30 days.

 5. Currently uses between 20 to 50 units/day basal insulin.

 Exclusion Criteria:

 1. Uncontrolled hyperglycemia, HbA1c > 9.0% requiring adjustment to his/her insulin
 regimen.

 2. Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir
 insulin without use of bolus/meal time insulin.

 3. Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days.

 4. Currently treated with sulfonylurea or incretin-based therapy [glucagon-like
 peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor].

 5. Total daily dose (TDD) of insulin is >100 units/day.

 6. Have a meal-time bolus doses that exceeds the capacity of the bolus Insulin Reservoir
 at any given meal.

 7. Have existing dermal irritation on their abdomen or have known hypersensitivity to
 skin adhesives.

 8. Taking or has taken prednisone or cortisone medications in the previous 30 days.

 9. Pregnant or is planning to become pregnant during the study period.

 10. Has severe medical or psychological condition(s) or chronic conditions/infections that
 in the opinion of the Investigator would compromise the patient's safety or successful
 participation in the study.

 11. Unable to follow the study clinical investigational plan (CIP)