Clinical trial NCT04315688: A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia
Official title: A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in laboratory measured glycated haemoglobin (HbA1c) (% point)
timeFrame: From baseline (week -12 to 0) to end of study (week 26-36)
measure: Change in laboratory measured HbA1c (mmol/mol)
timeFrame: From baseline (week -12 to 0) to end of study (week 26-36)
Secondary outcomes:
measure: Change in laboratory measured fasting plasma glucose (FPG)
timeFrame: From baseline (week -12 to 0) to end of study (week 26-36)
measure: Change in laboratory measured FPG
timeFrame: From baseline (week -12 to 0) to end of study (week 26-36)
measure: Change in daily insulin doses (basal insulin)
timeFrame: From baseline (week -12 to 0) to end of study (week 26-36)
measure: Change in daily insulin doses (prandial insulin)
timeFrame: From baseline (week -12 to 0) to end of study (week 26-36)
measure: Change in daily insulin doses (total insulin)
timeFrame: From baseline (week -12 to 0) to end of study (week 26-36)
measure: Change in number of patient reported overall non-severe hypoglycaemic episodes
timeFrame: 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)
measure: Change in number of patient reported nocturnal non-severe hypoglycaemic episodes
timeFrame: 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)
measure: Change in number of patient reported severe hypoglycaemic episodes (overall)
timeFrame: 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)
measure: Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options)
timeFrame: After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)
Other outcomes:
Locations:
city: Alushta
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Belogorsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Bryansk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Chapaevsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Dyurtyuli
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Elista
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ivanovo
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kaluga
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Krasnodar
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Lipetsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Lyskovo
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Magnitogorsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow Region, Dolgoprudny
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: N. Novgorod
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Odintsovo, Moscow Region
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Penza
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Penza
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Peterburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Peterburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Samara
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Sergiev Posad
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Sevastopol
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Sovetskiy
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Syktyvkar
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tula
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ufa
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Voskresensk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Vyksa
country: Russian Federation
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: