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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00773279

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	Device: PDS290 Device: Novo Nordisk marketed insulin pen	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Explore Effectiveness, Safety and Preference of a Comparator Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Subjects With Type 1 or Type 2 Diabetes

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 ]

Estimated Enrollment:	230
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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
B: Active Comparator	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

Arms

Assigned Interventions

A: Experimental

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

B: Active Comparator

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 64 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Gitte S. Fuchs

Novo Nordisk

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	PDS290-1971
Study First Received:	October 14, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00773279
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009