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A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
PaQ® Insulin Delivery Device
Insulin, Asp(B28)-
Sponsored by
CeQur Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin, Continuous subcutaneous insulin infusion (CSII), Insulin pumps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is at least 18 years of age;
  • Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage;
  • Has an A1C ≥ 7.0% and ≤ 11.0%;
  • Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or GLP-1 agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks, (See Section 7.4 for definition of baseline basal bolus therapy);
  • Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device;
  • If on concomitant metformin, has serum creatinine <1.5 mg/dL (male) or <1.4 mg/dL (female);
  • If female, and of child-bearing potential, has a negative urine pregnancy test at screening and must be using adequate means of contraception as determined by the Investigator;
  • Is clinically euthyroid as judged by the Investigator;
  • Is able to understand and sign the required study documents and comply with the CIP requirements;
  • Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose.

Exclusion Criteria:

  • Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator;
  • Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator;
  • Is currently taking or has taken sulfonylureas within the last 2 months;
  • Has a BMI greater than 40 kg/m2;
  • Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
  • Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator;
  • Has known clinically significant hypersensitivity to skin adhesives;
  • Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant;
  • Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route (inhaled with low systemic exposure is permitted);
  • Currently abuses drugs or alcohol or has a history of abuse that in the Investigator's opinion would cause the individual to be non-compliant;
  • Has received any investigational drug within 1 month;
  • Has donated blood within 30 days;
  • Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being;
  • Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site.

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PaQ® Insulin Delivery Device

Arm Description

The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments.

Outcomes

Primary Outcome Measures

Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)

Secondary Outcome Measures

Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Fasting plasma glucose
7-point blood glucose profiles
Total daily dose of insulin
Body weight
Barriers to Insulin Treatment questionnaire
Measures aspects of psychological obstacles to insulin treatment in people with type 2 diabetes.
Diabetes Treatment Satisfaction Questionnaire
Designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia.
Short form 36 Health Survey
It is a generic measure, as opposed to disease specific, which assesses the relative burden of diseases, and differentiates the health benefits produced by a wide range of different treatments.
Adverse events
Hypoglycemic events

Full Information

First Posted
March 24, 2015
Last Updated
July 25, 2016
Sponsor
CeQur Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02419859
Brief Title
A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
Official Title
A Prospective, Single Center Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CeQur Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
Detailed Description
This is a prospective, single center, open-label, uncontrolled study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (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 three phases: screening/baseline evaluation, transition to PaQ use and optimization, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin, Continuous subcutaneous insulin infusion (CSII), Insulin pumps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PaQ® Insulin Delivery Device
Arm Type
Experimental
Arm Description
The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments.
Intervention Type
Device
Intervention Name(s)
PaQ® Insulin Delivery Device
Intervention Description
PaQ is a 3 day insulin delivery device which delivers U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.
Intervention Type
Drug
Intervention Name(s)
Insulin, Asp(B28)-
Other Intervention Name(s)
NovoRapid
Intervention Description
a fast-acting analog of human insulin
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Time Frame
Change from Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Time Frame
Change from Baseline at 8 weeks
Title
Fasting plasma glucose
Time Frame
Change from Baseline at 12 weeks
Title
7-point blood glucose profiles
Time Frame
Change from Baseline at 12 weeks
Title
Total daily dose of insulin
Time Frame
Change from Baseline at 12 weeks
Title
Body weight
Time Frame
Change from Baseline at 12 weeks
Title
Barriers to Insulin Treatment questionnaire
Description
Measures aspects of psychological obstacles to insulin treatment in people with type 2 diabetes.
Time Frame
Change from Baseline at 12 weeks
Title
Diabetes Treatment Satisfaction Questionnaire
Description
Designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia.
Time Frame
Change from Baseline at 12 weeks
Title
Short form 36 Health Survey
Description
It is a generic measure, as opposed to disease specific, which assesses the relative burden of diseases, and differentiates the health benefits produced by a wide range of different treatments.
Time Frame
Change from Baseline at 12 weeks
Title
Adverse events
Time Frame
Collected throughout the study, average 14 weeks
Title
Hypoglycemic events
Time Frame
Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is at least 18 years of age; Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage; Has an A1C ≥ 7.0% and ≤ 11.0%; Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or GLP-1 agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks, (See Section 7.4 for definition of baseline basal bolus therapy); Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device; If on concomitant metformin, has serum creatinine <1.5 mg/dL (male) or <1.4 mg/dL (female); If female, and of child-bearing potential, has a negative urine pregnancy test at screening and must be using adequate means of contraception as determined by the Investigator; Is clinically euthyroid as judged by the Investigator; Is able to understand and sign the required study documents and comply with the CIP requirements; Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose. Exclusion Criteria: Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator; Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator; Is currently taking or has taken sulfonylureas within the last 2 months; Has a BMI greater than 40 kg/m2; Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months; Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator; Has known clinically significant hypersensitivity to skin adhesives; Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant; Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route (inhaled with low systemic exposure is permitted); Currently abuses drugs or alcohol or has a history of abuse that in the Investigator's opinion would cause the individual to be non-compliant; Has received any investigational drug within 1 month; Has donated blood within 30 days; Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being; Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pieber, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
No plan to share individual data sets, but will publish the results.
Citations:
PubMed Identifier
29888811
Citation
Mader JK, Lilly LC, Aberer F, Poettler T, Johns D, Trautmann M, Warner JL, Pieber TR. Improved glycaemic control and treatment satisfaction with a simple wearable 3-day insulin delivery device among people with Type 2 diabetes. Diabet Med. 2018 Oct;35(10):1448-1456. doi: 10.1111/dme.13708. Epub 2018 Jul 5.
Results Reference
derived

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A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

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