Type 2 Diabetes MellitusNCT02419859
A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
A study testing PaQ® Insulin Delivery Device and Insulin, Asp(B28)- in people with Type 2 Diabetes Mellitus, run by CeQur Corporation at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- PaQ® Insulin Delivery Device and Insulin, Asp(B28)-
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PaQ® Insulin Delivery Device, Insulin, Asp(B28)-
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin, Continuous subcutaneous insulin infusion (CSII), Insulin pumps
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaQ® Insulin Delivery DeviceDevice
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.
Insulin, Asp(B28)-Drug
Also called NovoRapid
a fast-acting analog of human insulin
| Study group | Role | What they receive |
|---|---|---|
| PaQ® Insulin Delivery Device | Experimental | 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. Receives: Device: PaQ® Insulin Delivery Device; Drug: Insulin, Asp(B28)- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Measured: Change from Baseline at 12 weeks
Secondary outcomes (10)
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Measured: Change from Baseline at 8 weeks
Fasting plasma glucose
Measured: Change from Baseline at 12 weeks
7-point blood glucose profiles
Measured: Change from Baseline at 12 weeks
Total daily dose of insulin
Measured: Change from Baseline at 12 weeks
Body weight
Measured: Change from Baseline at 12 weeks
Barriers to Insulin Treatment questionnaire
Measures aspects of psychological obstacles to insulin treatment in people with type 2 diabetes.
Measured: Change from Baseline at 12 weeks
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.
Measured: Change from Baseline at 12 weeks
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.
Measured: Change from Baseline at 12 weeks
Adverse events
Measured: Collected throughout the study, average 14 weeks
Hypoglycemic events
Measured: Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeQur Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Pieber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419859
- Sponsor's protocol ID
- CQR14002
- Status last verified
- Jul 2016
- First submitted
- 24 Mar 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: No plan to share individual data sets, but will publish the results.
Publications
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.
PubMed 29888811
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02419859
- Acronym / sponsor ID
- CQR14002
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CeQur CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PaQ® Insulin Delivery Device | Experimental | Device: PaQ® Insulin Delivery Device, Drug: Insulin, Asp(B28)-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaQ® Insulin Delivery DevicePaQ 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. | Device | PaQ® Insulin Delivery Device |
| Insulin, Asp(B28)-Also: NovoRapida fast-acting analog of human insulin | Drug | PaQ® Insulin Delivery Device |
Primary outcome
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Time frame: Change from Baseline at 12 weeks
10 secondary outcomes
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
Time frame: Change from Baseline at 8 weeks
Fasting plasma glucose
Time frame: Change from Baseline at 12 weeks
7-point blood glucose profiles
Time frame: Change from Baseline at 12 weeks
Total daily dose of insulin
Time frame: Change from Baseline at 12 weeks
Body weight
Time frame: Change from Baseline at 12 weeks
Barriers to Insulin Treatment questionnaire
Time frame: Change from Baseline at 12 weeks
Diabetes Treatment Satisfaction Questionnaire
Time frame: Change from Baseline at 12 weeks
Short form 36 Health Survey
Time frame: Change from Baseline at 12 weeks
Adverse events
Time frame: Collected throughout the study, average 14 weeks
Hypoglycemic events
Time frame: Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Derived from this study: PubMed 29888811Mader 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.
- Individual participant dataSharing planned: Yes. No plan to share individual data sets, but will publish the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Pieber, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PaQ® Insulin Delivery Device and Insulin, Asp(B28)- in people with Type 2 Diabetes Mellitus, run by CeQur Corporation at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) (time frame: Change from Baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.