Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is to investigate the effects of Fiasp®, a mealtime insulin, in patients with diabetes mellitus. The purpose of this study is to collect information about Fiasp®, which is prescribed to the participants by their doctors. Participants will administer Fiasp® as prescribed by their doctors. The study will last for about 6 months.
Interventions
DRUGFaster-acting insulin aspart
Faster-acting insulin aspart given as subcutaneous (s.c., under the skin) injections according to routine clinical practice. The decision to initiate treatment with commercially available Fiasp® must be made by the patient and the treating physician before and independently from the decision to include the patient in this study.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female, age equal to or above 18 years at the time of signing the informed consent. * Patients diagnosed with diabetes mellitus. * Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician.
Exclusion criteria
* Known or suspected hypersensitivity to study product(s) or related products. * Patients on or likely to use insulin pump therapy during the study period * Previous participation in this study. Participation is defined as having given signed informed consent. * Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation. * Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start. * Any disorder which in the opinion of the treating physician may jeopardise the patient's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | From start of treatment (Week 0) to End of Study Visit (Week 26) | Number of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events (SAEs) | From start of treatment (Week 0) to End of Study Visit (Week 26) | Number of events |
| Adverse Drug Reactions (ADRs) | From start of treatment (Week 0) to End of Study Visit (Week 26) | Number of events |
| Serious Adverse Drug Reactions (SADRs) | From start of treatment (Week 0) to End of Study Visit (Week 26) | Number of events |
| Patient reported severe hypoglycaemia | From start of treatment (Week 0) to End of Study Visit (Week 26) | Episodes/person-year |
| Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia | From start of treatment (Week 0) to End of Study Visit (Week 26) | Episodes/person-year |
| Patient reported Severe or BG confirmed (below 56 mg/dl) hypoglycaemia | From start of treatment (Week 0) to End of Study Visit (Week 26) | Episodes/person-year |
| Change in HbA1c | From start of treatment (Week 0) to End of Study Visit (Week 26) | Percent point (%) |
Countries
India
Contacts
STUDY_DIRECTORClinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed