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

This study has been completed.
Sponsor:
Collaborator:
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
CeQur Corporation
ClinicalTrials.gov Identifier:
NCT01535612
First received: September 2, 2011
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Device: PaQ™ continuous subcutaneous insulin infusion (CSII) device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CeQur Corporation:

Primary Outcome Measures:
  • Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device [ Time Frame: End of two week transition period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Insulin usage [ Time Frame: End of two baseline period and end of 2 week treatment period ] [ Designated as safety issue: Yes ]
    Average daily amount of basal insulin and meal time bolus insulin will be calculated

  • 7-point blood glucose reading [ Time Frame: Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6) ] [ Designated as safety issue: Yes ]
    7 - points are pre and 1.5 hours post each meal and at bedtime

  • Glucose variability [ Time Frame: During baseline and PaQ™ treatment period ] [ Designated as safety issue: Yes ]
    Continuous glucose montoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose varaibility during each time period will be calculated.

  • Glucose exposure [ Time Frame: During baseline and PaQ™ treatment period ] [ Designated as safety issue: Yes ]
    Continuous glucose montoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose exposure during each time period will be calculated.

  • Glucose Stability [ Time Frame: During baseline and PaQ™ Treatment Period ] [ Designated as safety issue: Yes ]
    Continuous glucose montoring (CGM) will be performed. Data stored in the CGM will be transferred to a computer at the end of each study period. Glucose stability during each time period will be calculated.

  • Infection at cannula insertion site [ Time Frame: During transition and PaQ™ treatment period ] [ Designated as safety issue: Yes ]
  • Occurence of adverse experiences and the number and severity of hypoglycemic episodes [ Time Frame: During baseline, transition and PaQ™ treatment period ] [ Designated as safety issue: Yes ]
  • Quality of Life Questionnaire [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Dermal Irritation [ Time Frame: During transition and PaQ™ treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PaQ™ continuous subcutaneous insulin infusion (CSII) device
    Basal/bolus insulin therapy administered by CSII for 4 weeks. First two weeks is transition period to identify correct basal rate for the patient, second 2 weeks is treatment period to evaluate efficacy of CSII device.
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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535612

Locations
Austria
Medical University of Graz
Graz, Austria, A-8036
Sponsors and Collaborators
CeQur Corporation
International Diabetes Center at Park Nicollet
Investigators
Principal Investigator: Thomas Pieber, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: CeQur Corporation
ClinicalTrials.gov Identifier: NCT01535612     History of Changes
Other Study ID Numbers: CQR-09001
Study First Received: September 2, 2011
Last Updated: April 12, 2013
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014