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

NCT ID: NCT00773279

Last Updated: 2017-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PDS290 --> FlexPen®

Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2)

Group Type EXPERIMENTAL

FlexTouch®

Intervention Type DEVICE

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®

Intervention Type DEVICE

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® --> PDS290

Subjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2)

Group Type EXPERIMENTAL

FlexTouch®

Intervention Type DEVICE

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®

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Mission Viejo, California, United States

Site Status

Novo Nordisk Investigational Site

Orange, California, United States

Site Status

Novo Nordisk Investigational Site

Poway, California, United States

Site Status

Novo Nordisk Investigational Site

Salinas, California, United States

Site Status

Novo Nordisk Investigational Site

Santa Monica, California, United States

Site Status

Novo Nordisk Investigational Site

Tustin, California, United States

Site Status

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Site Status

Novo Nordisk Investigational Site

Aurora, Colorado, United States

Site Status

Novo Nordisk Investigational Site

Colorado Springs, Colorado, United States

Site Status

Novo Nordisk Investigational Site

Golden, Colorado, United States

Site Status

Novo Nordisk Investigational Site

Boca Raton, Florida, United States

Site Status

Novo Nordisk Investigational Site

Hollywood, Florida, United States

Site Status

Novo Nordisk Investigational Site

Burlingame, California, United States

Site Status

Novo Nordisk Investigational Site

Concord, California, United States

Site Status

Novo Nordisk Investigational Site

Encino, California, United States

Site Status

Novo Nordisk Investigational Site

Escondido, California, United States

Site Status

Novo Nordisk Investigational Site

Fresno, California, United States

Site Status

Novo Nordisk Investigational Site

Maitland, Florida, United States

Site Status

Novo Nordisk Investigational Site

Miami, Florida, United States

Site Status

Novo Nordisk Investigational Site

Miami, Florida, United States

Site Status

Novo Nordisk Investigational Site

Ocala, Florida, United States

Site Status

Novo Nordisk Investigational Site

Tallahassee, Florida, United States

Site Status

Novo Nordisk Investigational Site

Athens, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Savannah, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Lafayette, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Wichita, Kansas, United States

Site Status

Novo Nordisk Investigational Site

Bowling Green, Kentucky, United States

Site Status

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Site Status

Novo Nordisk Investigational Site

Metairie, Louisiana, United States

Site Status

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Hyattsville, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Rockville, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Jefferson City, Missouri, United States

Site Status

Novo Nordisk Investigational Site

St Louis, Missouri, United States

Site Status

Novo Nordisk Investigational Site

Butte, Montana, United States

Site Status

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Site Status

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Site Status

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Site Status

Novo Nordisk Investigational Site

Berlin, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

Lawrenceville, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

Asheville, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Tabor City, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Fargo, North Dakota, United States

Site Status

Novo Nordisk Investigational Site

Dayton, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Gallipolis, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Kettering, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Mentor, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Medford, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Altoona, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Carlisle, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Little River, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Arlington, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Hurst, Texas, United States

Site Status

Novo Nordisk Investigational Site

San Antonio, Texas, United States

Site Status

Novo Nordisk Investigational Site

Ogden, Utah, United States

Site Status

Novo Nordisk Investigational Site

Virginia Beach, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Renton, Washington, United States

Site Status

Novo Nordisk Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Wielandt JO, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen. Expert Opin Drug Deliv. 2011 Oct;8(10):1271-6. doi: 10.1517/17425247.2011.615308. Epub 2011 Sep 2.

Reference Type RESULT
PMID: 21883036 (View on PubMed)

Garg S, Bailey T, DeLuzio T, Pollom D. Preference for a new prefilled insulin pen compared with the original pen. Curr Med Res Opin. 2011 Dec;27(12):2323-33. doi: 10.1185/03007995.2011.630721. Epub 2011 Oct 31.

Reference Type RESULT
PMID: 21988614 (View on PubMed)

Nadeau DA, Campos C, Niemeyer M, Bailey T. Healthcare professional and patient assessment of a new prefilled insulin pen versus two widely available prefilled insulin pens for ease of use, teaching and learning. Curr Med Res Opin. 2012 Jan;28(1):3-13. doi: 10.1185/03007995.2011.644427. Epub 2011 Dec 20.

Reference Type RESULT
PMID: 22114905 (View on PubMed)

Hemmingsen H, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. A prefilled insulin pen with a novel injection mechanism and a lower injection force than other prefilled insulin pens. Diabetes Technol Ther. 2011 Dec;13(12):1207-11. doi: 10.1089/dia.2011.0110. Epub 2011 Aug 24.

Reference Type RESULT
PMID: 21864019 (View on PubMed)

Bailey T, Thurman J, Niemeyer M, Schmeisl G. Usability and preference evaluation of a prefilled insulin pen with a novel injection mechanism by people with diabetes and healthcare professionals. Curr Med Res Opin. 2011 Oct;27(10):2043-52. doi: 10.1185/03007995.2011.616190. Epub 2011 Sep 14.

Reference Type RESULT
PMID: 21916529 (View on PubMed)

Oyer D, Narendran P, Qvist M, Niemeyer M, Nadeau DA. Ease of use and preference of a new versus widely available prefilled insulin pen assessed by people with diabetes, physicians and nurses. Expert Opin Drug Deliv. 2011 Oct;8(10):1259-69. doi: 10.1517/17425247.2011.615830. Epub 2011 Sep 12.

Reference Type RESULT
PMID: 21905942 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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PDS290-1971

Identifier Type: -

Identifier Source: org_study_id

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