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

February 6, 2017 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 3

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

  • United States
    • California
      • Burlingame, California, United States, 94010
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Encino, California, United States, 91436
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Mission Viejo, California, United States, 92691
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92869
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • Salinas, California, United States, 93901
        • Novo Nordisk Investigational Site
      • Santa Monica, California, United States, 90404
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Investigational Site
      • Golden, Colorado, United States, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Maitland, Florida, United States, 32751
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33143
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60616
        • Novo Nordisk Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47904
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Novo Nordisk Investigational Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101-1759
        • Novo Nordisk Investigational Site
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Novo Nordisk Investigational Site
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89030
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89101
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Tabor City, North Carolina, United States, 28463
        • Novo Nordisk Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Novo Nordisk Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Gallipolis, Ohio, United States, 45631-1560
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504-8491
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Carlisle, Pennsylvania, United States, 17015
        • Novo Nordisk Investigational Site
    • South Carolina
      • Little River, South Carolina, United States, 29566
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Novo Nordisk Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Novo Nordisk Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Novo Nordisk Investigational Site

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDS290 --> FlexPen®
Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2)
Device: FlexTouch®
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.
Device: FlexPen®
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.
Experimental: FlexPen® --> PDS290
Subjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2)
Device: FlexTouch®
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.
Device: FlexPen®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®
Time Frame: Week 12 of each treatment sequence
Week 12 of each treatment sequence

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use
Time Frame: Week 24
Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)
Week 24
Summary Score for Treatment Satisfaction
Time Frame: Week 24
Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.
Week 24
Score for Treatment Impact Measure for Diabetes
Time Frame: Week 24
Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.
Week 24
Clinical Technical Complaints (CTCs)
Time Frame: Weeks 0-24 (whole trial period)
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.
Weeks 0-24 (whole trial period)
Number of Hypoglycaemic Episodes
Time Frame: Weeks 0-12 (first treatment) and 12-24 (second treatment)
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.
Weeks 0-12 (first treatment) and 12-24 (second treatment)
Number of Adverse Device Effects
Time Frame: From randomisation (week 0) and until 7 days after Week 24 (Visit 16)
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.
From randomisation (week 0) and until 7 days after Week 24 (Visit 16)
Hypoglycaemic Episodes, Number of Events Per Subject Day
Time Frame: Weeks 0-12 (first treatment) and 12-24 (second treatment)
Weeks 0-12 (first treatment) and 12-24 (second treatment)

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

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

Helpful Links

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

September 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDS290-1971

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on FlexTouch®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe