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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773279
• Other study ID #: PDS290-1971
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2008
• Last updated: October 14, 2013
• Start date: September 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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®) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delivery Systems
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Altoona	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Arlington	Texas
United States	Novo Nordisk Clinical Trial Call Center	Asheville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Athens	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Aurora	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Baltimore	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Berlin	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Boca Raton	Florida
United States	Novo Nordisk Clinical Trial Call Center	Bowling Green	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Burlingame	California
United States	Novo Nordisk Clinical Trial Call Center	Butte	Montana
United States	Novo Nordisk Clinical Trial Call Center	Carlisle	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Colorado Springs	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Concord	California
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Encino	California
United States	Novo Nordisk Clinical Trial Call Center	Escondido	California
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Gallipolis	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Golden	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Hollywood	Florida
United States	Novo Nordisk Clinical Trial Call Center	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	Hurst	Texas
United States	Novo Nordisk Clinical Trial Call Center	Hyattsville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Jefferson City	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Jefferson City	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Kettering	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Lafayette	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Little River	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Maitland	Florida
United States	Novo Nordisk Clinical Trial Call Center	Mentor	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Milwaukee	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Mission Viejo	California
United States	Novo Nordisk Clinical Trial Call Center	Ocala	Florida
United States	Novo Nordisk Clinical Trial Call Center	Ogden	Utah
United States	Novo Nordisk Clinical Trial Call Center	Omaha	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Orange	California
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Roswell	Georgia
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Santa Monica	California
United States	Novo Nordisk Clinical Trial Call Center	Savannah	Georgia
United States	Novo Nordisk Clinical Trial Call Center	St. Louis	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Tabor City	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Tallahassee	Florida
United States	Novo Nordisk Clinical Trial Call Center	Tustin	California
United States	Novo Nordisk Clinical Trial Call Center	Virginia Beach	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California
United States	Novo Nordisk Clinical Trial Call Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c (glycosylated haemoglobin) for participants treated with PDS290 and FlexPen®		Week 12 of each treatment sequence	No
Secondary	Percentage of subject having preference for PDS290 versus FlexPen® in terms of convenience and ease of use		Week 24	No
Secondary	Summary score for treatment satisfaction		Week 24	No
Secondary	Score for treatment impact measure for diabetes		Week 24	No
Secondary	Clinical technical complaints (events/week)		Week 0 to Week 24 (whole trial period)	No
Secondary	Number of hypoglycaemic episodes		Week 24	No
Secondary	Number of adverse device effects		From randomisation (week 0) and until 7 days after Week 24 (Visit 16)	No
Secondary	Hypoglycaemic episodes, number of events per subject day		Week 24	No

External Links

•   Clinical Trials at Novo Nordisk