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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00773279
First received: October 14, 2008
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  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 comparator insulin pen PDS290 versus a Novo Nordisk marketed insulin pen 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 Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
 Device: PDS290
Device: Novo Nordisk marketed insulin pen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
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 vs. FlexPen® in Subjects With Type 1 or Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical technical complains [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Compare the effectiveness of PDS290 vs a Novo Nordisk marketed insulin pen using questionnaires [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Adverse events and adverse device effects [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 255
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: A Device: PDS290

All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a comparator insulin pen PDS290 or a Novo Nordisk marketed insulin pen for 12 weeks.

After 12 weeks, all subjects will continue their insulin treatment with the other injection device

Device: Novo Nordisk marketed insulin pen

All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a comparator insulin pen PDS290 or a Novo Nordisk marketed insulin pen for 12 weeks.

After 12 weeks, all subjects will continue their insulin treatment with the other injection device
Active Comparator: B Device: PDS290

All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a comparator insulin pen PDS290 or a Novo Nordisk marketed insulin pen for 12 weeks.

After 12 weeks, all subjects will continue their insulin treatment with the other injection device

Device: Novo Nordisk marketed insulin pen

All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a comparator insulin pen PDS290 or a Novo Nordisk marketed insulin pen 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
Genders Eligible for Study:   Both
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/m2
  • 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 (NYHA 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773279

  Show 60 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Gitte S. Fuchs Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00773279     History of Changes
Other Study ID Numbers: PDS290-1971
Study First Received: October 14, 2008
Last Updated: January 25, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013