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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by CeQur Corporation
Sponsor:
Information provided by (Responsible Party):
CeQur Corporation
ClinicalTrials.gov Identifier:
NCT02158078
First received: June 4, 2014
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Type 2 Diabetes Mellitus
Device: PaQ® Insulin Delivery Device

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by CeQur Corporation:

Primary Outcome Measures:
  • Change in glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) from baseline at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in A1C from baseline at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose from baseline at end of study week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in insulin dose (total, basal, and bolus) from Baseline at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in body weight from baseline at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurrence of hypoglycemia, adverse events, and/or dermal irritation at PaQ application site [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Change in measures of PROs from baseline at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PaQ® Insulin Delivery Device
    PaQ is a 3 day insulin delivery device. Utilizes 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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 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
  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: NCT02158078

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, A-8036
Contact: Julia Mader, MD    0043 316 385 12383    julia.mader@healthsite.at   
Principal Investigator: Thomas Pieber, MD         
Sponsors and Collaborators
CeQur Corporation
Investigators
Principal Investigator: Thomas Pieber, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: CeQur Corporation
ClinicalTrials.gov Identifier: NCT02158078     History of Changes
Other Study ID Numbers: CQR13002
Study First Received: June 4, 2014
Last Updated: June 6, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by CeQur Corporation:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Continuous subcutaneous insulin infusion (CSII)
Insulin pumps

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

ClinicalTrials.gov processed this record on August 25, 2014