Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics
