Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus

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

• Male/female patient's ≥ 30 ≤ 65 years of age.
• Clinical confirmation of T2DM diagnosis by history and medication usage or glucose tolerance test.
• Currently treated with insulin using a basal/bolus regimen with or without concurrent use of OADs (metformin and/or glitazone).
• 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.
• Currently uses between 20 to 50 units/day basal insulin.

Exclusion criteria

• Uncontrolled hyperglycemia, HbA1c > 9.0% requiring adjustment to his/her insulin regimen.
• Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir insulin without use of bolus/meal time insulin.
• Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days.
• Currently treated with sulfonylurea or incretin-based therapy [glucagon-like peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor].
• Total daily dose (TDD) of insulin is >100 units/day.
• Have a meal-time bolus doses that exceeds the capacity of the bolus Insulin Reservoir at any given meal.
• Have existing dermal irritation on their abdomen or have known hypersensitivity to skin adhesives.
• Taking or has taken prednisone or cortisone medications in the previous 30 days.
• Pregnant or is planning to become pregnant during the study period.
• 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.
• Unable to follow the study clinical investigational plan (CIP)