Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: FlexTouch®; FlexPen®
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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/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