Health Condition 1: E08-E13- Diabetes mellitus
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 2. Male or female, age >= 1 years at the time of signing the informed consent. 3. Patients diagnosed with diabetes mellitus. 4. Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician.
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to study product(s) or related products. 2. Patients on or likely to use insulin pump therapy during the study period 3. Previous participation in this study. Participation is defined as having given signed informed consent. 4. Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation. 5. Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start. 6. Any disorder which in the opinion of the treating physician may jeopardise the patientâ??s safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs)Timepoint: End of Study Visit (Week 26) | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Events (SAEs) Adverse Drug Reactions (ADRs) Serious Adverse Drug Reactions (SADRs) Patient reported severe hypoglycaemia Patient reported BG confirmed (56 mg/dl) hypoglycaemia Patient reported Severe or BG confirmed (56 mg/dl) hypoglycaemiaTimepoint: End of Study Visit (Week 26) | — |
Countries
India
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed