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

CeQur Corporation1 site in 1 country20 target enrollmentMarch 2012

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: CeQur Corporation
Enrollment: 20
Locations: 1
Primary Endpoint: Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

September 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CeQur Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device

Time Frame: End of two week transition period

Secondary Outcomes

Infection at cannula insertion site(During transition and PaQ™ treatment period)
Occurence of adverse experiences and the number and severity of hypoglycemic episodes(During baseline, transition and PaQ™ treatment period)
Quality of Life Questionnaire(At the end of the study)
Dermal Irritation(During transition and PaQ™ treatment period)
Insulin usage(End of two baseline period and end of 2 week treatment period)
7-point blood glucose reading(Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6))
Glucose variability(During baseline and PaQ™ treatment period)
Glucose exposure(During baseline and PaQ™ treatment period)
Glucose Stability(During baseline and PaQ™ Treatment Period)