Clinical trial NCT01535612: Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus
Official title: A Study Evaluating the Feasibility of Use and Performance of PaQ™ in Patients With Type 2 Diabetes Mellitus Who Are Currently Treated With Basal/Bolus Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: CeQur Corporation
Sponsor class: INDUSTRY
Collaborators: name: International Diabetes Center at Park Nicollet
First posted: 2012-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device
timeFrame: End of two week transition period
Secondary outcomes:
measure: Insulin usage
timeFrame: End of two baseline period and end of 2 week treatment period
measure: 7-point blood glucose reading
timeFrame: Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6)
measure: Glucose variability
timeFrame: During baseline and PaQ™ treatment period
measure: Glucose exposure
timeFrame: During baseline and PaQ™ treatment period
measure: Glucose Stability
timeFrame: During baseline and PaQ™ Treatment Period
measure: Infection at cannula insertion site
timeFrame: During transition and PaQ™ treatment period
measure: Occurence of adverse experiences and the number and severity of hypoglycemic episodes
timeFrame: During baseline, transition and PaQ™ treatment period
measure: Quality of Life Questionnaire
timeFrame: At the end of the study
measure: Dermal Irritation
timeFrame: During transition and PaQ™ treatment period
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Thomas Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mader JK, Lilly LC, Aberer F, Korsatko S, Strock E, Mazze RS, Damsbo P, Pieber TR. A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes. Diabetes Care. 2014 May;37(5):1476-9. doi: 10.2337/dc13-2238. Epub 2014 Mar 5.