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

September 2, 2011
April 12, 2013
March 2012
August 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01535612 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 CeQur 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 CeQur 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 CeQur 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 CeQur 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 CeQur 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 CeQur 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 CeQur treatment period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus
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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2012
August 2012   (final data collection date for primary outcome measure)

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)
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01535612
CQR-09001
No
CeQur Corporation
CeQur Corporation
International Diabetes Center at Park Nicollet
Principal Investigator: Thomas Pieber, MD Medical University of Graz
CeQur Corporation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP