AzTrials
AzTrials

DiabetesPhase 3NCT00773279

Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics

A Phase 3 study testing FlexTouch® and FlexPen® in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess and compare the effect on blood sugar control of insulin detemir and insulin aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch®) versus a Novo Nordisk marketed insulin pen (FlexPen®)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FlexTouch® and FlexPen®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
65 sitesUnited States
Study dates
Sep 2008to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Informed consent obtained before any trial-related activities
  • Subjects diagnosed with type 1 or type 2 diabetes. If type 2 diabetics, treatment with or without oral anti diabetic medication is allowed
  • Current users of vial/syringe (pen naïve) treated with short-acting insulin (insulin aspart, glulisine or lispro) and once daily long-acting insulin (detemir or glargine) or once daily long-acting insulin (detemir or glargine) alone
  • Treatment with insulin (i.e. aspart, glulisine, lispro, detemir or glargine) for at least 6 months
  • Body Mass Index (BMI) less than 45.0 kg/m^2
  • HbA1c less than or equal to 9.0% at screening visit based on analysis from central laboratory
  • Able and willing to adhere to the trial-specific insulin regimen for the entire trial period

Who cannot join

  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or inadequate contraceptive techniques during the trial period (adequate contraceptive measures are considered as intrauterine device, oral contraceptives and barrier methods)
  • Previous participation in this trial (screening visit)
  • Systemic drugs that may influence glycaemic control (e.g., corticosteroids)
  • Known or suspected allergy to trial product(s) or related products
  • Known or suspected abuse of alcohol or drug abuse
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Show all 13Show fewer
  • Previous treatment with sitagliptin
  • Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, or haematological systems
  • Cardiac disease defined as: Decompensated heart failure (New York Heart class III or IV, unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on electrocardiogram (ECG) over the past 12 months
  • Any other severe acute or chronic illness as judged by the Investigator
  • Recurrent major hypoglycaemia (defined as severe central nervous system dysfunction associated with hypoglycaemia, requiring the assistance of another person) or hypoglycaemia unawareness (defined as a condition in which subjects no longer experience the usual warning signs of hypoglycaemia; the symptoms of hypoglycaemia may be different, less pronounced or even absent) or hospitalisation for diabetic ketoacidosis during the previous six months
  • Any other conditions that the Investigator judges would interfere with trial participation or evaluation of results (i.e. planned any diagnostic or therapeutic medical intervention such as surgery)
  • Participated in another clinical trial and received an investigational drug within the last 4 weeks

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania, 16602

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76014

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28803

  • Novo Nordisk Investigational Site

    Athens, Georgia, 30606

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30318

  • Novo Nordisk Investigational Site

    Aurora, Colorado, 80045

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21204

  • Novo Nordisk Investigational Site

    Berlin, New Jersey, 08009

  • Novo Nordisk Investigational Site

    Boca Raton, Florida, 33433

  • Novo Nordisk Investigational Site

    Bowling Green, Kentucky, 42101-1759

  • Novo Nordisk Investigational Site

    Burlingame, California, 94010

  • Novo Nordisk Investigational Site

    Butte, Montana, 59701

  • Novo Nordisk Investigational Site

    Carlisle, Pennsylvania, 17015

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60616

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80909

  • Novo Nordisk Investigational Site

    Concord, California, 94520

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45439

  • Novo Nordisk Investigational Site

    Encino, California, 91436

  • Novo Nordisk Investigational Site

    Escondido, California, 92025

  • Novo Nordisk Investigational Site

    Fargo, North Dakota, 58104

  • Novo Nordisk Investigational Site

    Fresno, California, 93720

  • Novo Nordisk Investigational Site

    Gallipolis, Ohio, 45631-1560

  • Novo Nordisk Investigational Site

    Golden, Colorado, 80401

  • Novo Nordisk Investigational Site

    Hollywood, Florida, 33021

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii, 96814

  • Novo Nordisk Investigational Site

    Hurst, Texas, 76054

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Jefferson City, Missouri, 65109

  • Novo Nordisk Investigational Site

    Kettering, Ohio, 45429

  • Novo Nordisk Investigational Site

    Lafayette, Indiana, 47904

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89030

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89101

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey, 08648

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Little River, South Carolina, 29566

  • Novo Nordisk Investigational Site

    Maitland, Florida, 32751

  • Novo Nordisk Investigational Site

    Medford, Oregon, 97504-8491

  • Novo Nordisk Investigational Site

    Mentor, Ohio, 44060

  • Novo Nordisk Investigational Site

    Metairie, Louisiana, 70002

  • Novo Nordisk Investigational Site

    Miami, Florida, 33143

  • Novo Nordisk Investigational Site

    Miami, Florida, 33156

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53209

  • Novo Nordisk Investigational Site

    Mission Viejo, California, 92691

  • Novo Nordisk Investigational Site

    Ocala, Florida, 34471

  • Novo Nordisk Investigational Site

    Ogden, Utah, 84403

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68114

  • Novo Nordisk Investigational Site

    Orange, California, 92869

  • Novo Nordisk Investigational Site

    Poway, California, 92064

  • Novo Nordisk Investigational Site

    Renton, Washington, 98057

  • Novo Nordisk Investigational Site

    Rockville, Maryland, 20852

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Salinas, California, 93901

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    Santa Monica, California, 90404

  • Novo Nordisk Investigational Site

    Savannah, Georgia, 31406

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63141

  • Novo Nordisk Investigational Site

    Tabor City, North Carolina, 28463

  • Novo Nordisk Investigational Site

    Tallahassee, Florida, 32308

  • Novo Nordisk Investigational Site

    Tustin, California, 92780

  • Novo Nordisk Investigational Site

    Virginia Beach, Virginia, 23462

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: A Multi-centre, Randomised, Open-label, Cross-over Study to Explore Effectiveness, Safety, and Preference of a New Disposable Pen PDS290 Versus FlexPen® in Subjects With Type 1 or Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess and compare the effect on blood sugar control of insulin detemir and insulin aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch®) versus a Novo Nordisk marketed insulin pen (FlexPen®) in subjects with type 1 or type 2 diabetes mellitus. Furthermore, the subject's preference of the devices will be investigated by the use of questionnaires.

Being tested
FlexTouch®, FlexPen®
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlexTouch®Device

    All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.

  • FlexPen®Device

    All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.

Study groups in NCT00773279
Study groupRoleWhat they receive
PDS290 --> FlexPen®ExperimentalSubjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2)
Receives: Device: FlexTouch®; Device: FlexPen®
FlexPen® --> PDS290ExperimentalSubjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2)
Receives: Device: FlexTouch®; Device: FlexPen®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®

    Measured: Week 12 of each treatment sequence

Secondary outcomes (7)

  1. Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use

    Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)

    Measured: Week 24

  2. Summary Score for Treatment Satisfaction

    Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.

    Measured: Week 24

  3. Score for Treatment Impact Measure for Diabetes

    Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.

    Measured: Week 24

  4. Clinical Technical Complaints (CTCs)

    A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.

    Measured: Weeks 0-24 (whole trial period)

  5. Number of Hypoglycaemic Episodes

    Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.

    Measured: Weeks 0-12 (first treatment) and 12-24 (second treatment)

  6. Number of Adverse Device Effects

    Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.

    Measured: From randomisation (week 0) and until 7 days after Week 24 (Visit 16)

  7. Hypoglycaemic Episodes, Number of Events Per Subject Day

    Measured: Weeks 0-12 (first treatment) and 12-24 (second treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00773279
Sponsor's protocol ID
PDS290-1971
Status last verified
Feb 2017
First submitted
14 Oct 2008
Last updated
27 Mar 2017
Data monitoring committee
No

Publications

  • Wielandt JO, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen. Expert Opin Drug Deliv. 2011 Oct;8(10):1271-6. doi: 10.1517/17425247.2011.615308. Epub 2011 Sep 2.

    PubMed 21883036

  • Garg S, Bailey T, DeLuzio T, Pollom D. Preference for a new prefilled insulin pen compared with the original pen. Curr Med Res Opin. 2011 Dec;27(12):2323-33. doi: 10.1185/03007995.2011.630721. Epub 2011 Oct 31.

    PubMed 21988614

  • Nadeau DA, Campos C, Niemeyer M, Bailey T. Healthcare professional and patient assessment of a new prefilled insulin pen versus two widely available prefilled insulin pens for ease of use, teaching and learning. Curr Med Res Opin. 2012 Jan;28(1):3-13. doi: 10.1185/03007995.2011.644427. Epub 2011 Dec 20.

    PubMed 22114905

  • Hemmingsen H, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. A prefilled insulin pen with a novel injection mechanism and a lower injection force than other prefilled insulin pens. Diabetes Technol Ther. 2011 Dec;13(12):1207-11. doi: 10.1089/dia.2011.0110. Epub 2011 Aug 24.

    PubMed 21864019

  • Bailey T, Thurman J, Niemeyer M, Schmeisl G. Usability and preference evaluation of a prefilled insulin pen with a novel injection mechanism by people with diabetes and healthcare professionals. Curr Med Res Opin. 2011 Oct;27(10):2043-52. doi: 10.1185/03007995.2011.616190. Epub 2011 Sep 14.

    PubMed 21916529

  • Oyer D, Narendran P, Qvist M, Niemeyer M, Nadeau DA. Ease of use and preference of a new versus widely available prefilled insulin pen assessed by people with diabetes, physicians and nurses. Expert Opin Drug Deliv. 2011 Oct;8(10):1259-69. doi: 10.1517/17425247.2011.615830. Epub 2011 Sep 12.

    PubMed 21905942

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FlexTouch® and FlexPen® in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 65 sites in United States.

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 7 inclusion and 13 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen® (time frame: Week 12 of each treatment sequence). 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 NCT00773279, which also lists 6 linked publications.

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 27 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in