NCT00773279|CompletedPhase 3Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

PDS290-1971

Study Type

interventional

Target

242

Locations

1 country

Sites

Timeline

RegisteredOct 2008

StartedSep 2008

CompletionJun 2009

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

242

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Sep 2008

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

65 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

September 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed

7.8 years until next milestone

Results Posted

Study results publicly available

March 27, 2017

Completed

Last Updated

March 27, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

October 14, 2008

Results QC Date

October 12, 2015

Last Update Submit

February 6, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®
Week 12 of each treatment sequence

Secondary Outcomes (7)

Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use
Week 24
Summary Score for Treatment Satisfaction
Week 24
Score for Treatment Impact Measure for Diabetes
Week 24
Clinical Technical Complaints (CTCs)
Weeks 0-24 (whole trial period)
Number of Hypoglycaemic Episodes
Weeks 0-12 (first treatment) and 12-24 (second treatment)
+2 more secondary outcomes

Study Arms (2)

PDS290 --> FlexPen®

EXPERIMENTAL

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

Device: FlexTouch®Device: FlexPen®

FlexPen® --> PDS290

EXPERIMENTAL

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

Device: FlexTouch®Device: FlexPen®

Interventions

FlexTouch®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® --> PDS290PDS290 --> FlexPen®

FlexPen®DEVICE

FlexPen® --> PDS290PDS290 --> FlexPen®

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.