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

Phase 3

Completed

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

Interventions: Device: FlexTouch®
Device: FlexPen®

Registration Number: NCT00773279

Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 242

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

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PDS290 --> FlexPen®	FlexPen®	Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2)
FlexPen® --> PDS290	FlexTouch®	Subjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2)
PDS290 --> FlexPen®	FlexTouch®	Subjects will receive trial drug with PDS290 for 12 weeks (treatment sequence 1) followed by FlexPen® for 12 weeks (treatment sequence 2)
FlexPen® --> PDS290	FlexPen®	Subjects will receive trial drug with FlexPen® for 12 weeks (treatment sequence 1) followed by PDS290 for 12 weeks (treatment sequence 2)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hypoglycaemic Episodes, Number of Events Per Subject Day	Weeks 0-12 (first treatment) and 12-24 (second treatment)
Score for Treatment Impact Measure for Diabetes	Week 24	Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.
Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use	Week 24	Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)
Summary Score for Treatment Satisfaction	Week 24	Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.
Number of Hypoglycaemic Episodes	Weeks 0-12 (first treatment) and 12-24 (second treatment)	Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.
Number of Adverse Device Effects	From randomisation (week 0) and until 7 days after Week 24 (Visit 16)	Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.
Clinical Technical Complaints (CTCs)	Weeks 0-24 (whole trial period)	A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.