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

July 25, 2016 updated by: CeQur Corporation

A Prospective, Single Center, Post-Market Observational Study to Assess the Efficacy, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single center, post-market observational 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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Twenty five (25) individuals with T2DM who have an A1C of 7.0% to 11.0%, inclusive, at Screening (Visit 1) will be recruited at one investigative site.

Description

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 glucagon-like peptide-1 (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
  • 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 clinical investigational plan (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in A1C from baseline at Week 8
Time Frame: 8 weeks
8 weeks
Change in fasting plasma glucose from baseline at end of study week 12
Time Frame: 12 weeks
12 weeks
Change in 7-point blood glucose profiles and 1.5-2 hour postprandial blood glucose excursions (average and by meal) from baseline at week 12
Time Frame: 12 weeks
12 weeks
Change in insulin dose (total, basal, and bolus) from Baseline at week 12
Time Frame: 12 weeks
12 weeks
Change in body weight from baseline at Week 12
Time Frame: 12 weeks
12 weeks
Occurrence of hypoglycemia, adverse events, and/or dermal irritation at PaQ application site
Time Frame: Throughout the study
Throughout the study
Change in measures of PROs from baseline at Week 12
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CeQur Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (ESTIMATE)

June 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQR13002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

No plan to share individual data sets, but will publish results.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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