Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of the study is to collect information on how Tresiba® works in real world patients with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.
Interventions
DRUGinsulin degludec
Treatment with Tresiba® with or without anti-diabetes medication (as per local label), as prescribed by the participant's physician. The study population will include adult patients with type 2 diabetes, both insulin naïve and previously insulin treated, for whom the treating physician has decided to initiate treatment with Tresiba®, independent of the decision to include the patient in the 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
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * The decision to initiate treatment with commercially available Tresiba® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study. * Male or female, age above or equal to 18 years at the time of signing informed consent. * Diagnosed with type 2 diabetes and treated with any antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1). * Available and documented HbA1c value 12 weeks or less prior to initiation of Tresiba® treatment.
Exclusion criteria
* Previous participation in this study. Participation is defined as having given informed consent in this study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Hypersensitivity to the active substance or to any of the excipients as specified in the Tresiba® local label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in laboratory measured glycated haemoglobin (HbA1c) (% point) | From baseline (week -12 to 0) to end of study (week 26-36) | % point |
| Change in laboratory measured HbA1c (mmol/mol) | From baseline (week -12 to 0) to end of study (week 26-36) | mmol/mol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily insulin doses (basal insulin) | From baseline (week -12 to 0) to end of study (week 26-36) | units/day |
| Change in daily insulin doses (prandial insulin) | From baseline (week -12 to 0) to end of study (week 26-36) | units/day |
| Change in daily insulin doses (total insulin) | From baseline (week -12 to 0) to end of study (week 26-36) | units/day |
| Change in laboratory measured fasting plasma glucose (FPG) | From baseline (week -12 to 0) to end of study (week 26-36) | mg/dL |
| Change in number of patient reported nocturnal non-severe hypoglycaemic episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) | Number of episodes |
| Change in number of patient reported severe hypoglycaemic episodes (overall) | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) | Number of episodes |
| Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options) | After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36) | Number of participants per response option |
| Change in number of patient reported overall non-severe hypoglycaemic episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) | Number of episodes |
| Change in laboratory measured FPG | From baseline (week -12 to 0) to end of study (week 26-36) | mmol/L |
Countries
Russia
Outcome results
None listed