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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00773279
First received: October 14, 2008
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Device: FlexTouch®
Device: FlexPen®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen® [ Time Frame: Week 12 of each treatment sequence ]

Secondary Outcome Measures:
  • 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)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Hypoglycaemic Episodes, Number of Events Per Subject Day [ Time Frame: Weeks 0-12 (first treatment) and 12-24 (second treatment) ]

Enrollment: 242
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00773279

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
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
United States, Colorado
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80909
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Investigational Site
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
United States, Georgia
Novo Nordisk Investigational Site
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
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60616
United States, Indiana
Novo Nordisk Investigational Site
Lafayette, Indiana, United States, 47904
United States, Kansas
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67226
United States, Kentucky
Novo Nordisk Investigational Site
Bowling Green, Kentucky, United States, 42101-1759
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21204
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Missouri
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States, 65109
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63141
United States, Montana
Novo Nordisk Investigational Site
Butte, Montana, United States, 59701
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89030
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89101
United States, New Jersey
Novo Nordisk Investigational Site
Berlin, New Jersey, United States, 08009
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
Novo Nordisk Investigational Site
Tabor City, North Carolina, United States, 28463
United States, North Dakota
Novo Nordisk Investigational Site
Fargo, North Dakota, United States, 58104
United States, Ohio
Novo Nordisk Investigational Site
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
United States, Oregon
Novo Nordisk Investigational Site
Medford, Oregon, United States, 97504-8491
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Carlisle, Pennsylvania, United States, 17015
United States, South Carolina
Novo Nordisk Investigational Site
Little River, South Carolina, United States, 29566
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
United States, Texas
Novo Nordisk Investigational Site
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
United States, Utah
Novo Nordisk Investigational Site
Ogden, Utah, United States, 84403
United States, Virginia
Novo Nordisk Investigational Site
Virginia Beach, Virginia, United States, 23462
United States, Washington
Novo Nordisk Investigational Site
Renton, Washington, United States, 98057
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00773279     History of Changes
Other Study ID Numbers: PDS290-1971
Study First Received: October 14, 2008
Results First Received: October 12, 2015
Last Updated: February 6, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017