A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315688
• Other study ID #: NN1250-4589
• Secondary ID: U1111-1236-4887
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: August 2, 2021

Study information

• Verified date: August 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: August 2, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin 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.

Locations

Country	Name	City	State
Russian Federation	Novo Nordisk Investigational Site	Alushta
Russian Federation	Novo Nordisk Investigational Site	Belogorsk
Russian Federation	Novo Nordisk Investigational Site	Bryansk
Russian Federation	Novo Nordisk Investigational Site	Chapaevsk
Russian Federation	Novo Nordisk Investigational Site	Chelyabinsk
Russian Federation	Novo Nordisk Investigational Site	Dyurtyuli
Russian Federation	Novo Nordisk Investigational Site	Elista
Russian Federation	Novo Nordisk Investigational Site	Ivanovo
Russian Federation	Novo Nordisk Investigational Site	Kaluga
Russian Federation	Novo Nordisk Investigational Site	Kazan
Russian Federation	Novo Nordisk Investigational Site	Krasnodar
Russian Federation	Novo Nordisk Investigational Site	Krasnoyarsk
Russian Federation	Novo Nordisk Investigational Site	Krasnoyarsk
Russian Federation	Novo Nordisk Investigational Site	Lipetsk
Russian Federation	Novo Nordisk Investigational Site	Lyskovo
Russian Federation	Novo Nordisk Investigational Site	Magnitogorsk
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow Region, Dolgoprudny
Russian Federation	Novo Nordisk Investigational Site	N. Novgorod
Russian Federation	Novo Nordisk Investigational Site	Odintsovo, Moscow Region
Russian Federation	Novo Nordisk Investigational Site	Penza
Russian Federation	Novo Nordisk Investigational Site	Penza
Russian Federation	Novo Nordisk Investigational Site	Rostov-on-Don
Russian Federation	Novo Nordisk Investigational Site	Saint-Peterburg
Russian Federation	Novo Nordisk Investigational Site	Saint-Peterburg
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Samara
Russian Federation	Novo Nordisk Investigational Site	Saratov
Russian Federation	Novo Nordisk Investigational Site	Saratov
Russian Federation	Novo Nordisk Investigational Site	Sergiev Posad
Russian Federation	Novo Nordisk Investigational Site	Sevastopol
Russian Federation	Novo Nordisk Investigational Site	Sovetskiy
Russian Federation	Novo Nordisk Investigational Site	St. Petersburg
Russian Federation	Novo Nordisk Investigational Site	Syktyvkar
Russian Federation	Novo Nordisk Investigational Site	Tula
Russian Federation	Novo Nordisk Investigational Site	Ufa
Russian Federation	Novo Nordisk Investigational Site	Voskresensk
Russian Federation	Novo Nordisk Investigational Site	Vyksa

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in laboratory measured glycated haemoglobin (HbA1c) (% point)	% point	From baseline (week -12 to 0) to end of study (week 26-36)
Primary	Change in laboratory measured HbA1c (mmol/mol)	mmol/mol	From baseline (week -12 to 0) to end of study (week 26-36)
Secondary	Change in laboratory measured fasting plasma glucose (FPG)	mg/dL	From baseline (week -12 to 0) to end of study (week 26-36)
Secondary	Change in laboratory measured FPG	mmol/L	From baseline (week -12 to 0) to end of study (week 26-36)
Secondary	Change in daily insulin doses (basal insulin)	units/day	From baseline (week -12 to 0) to end of study (week 26-36)
Secondary	Change in daily insulin doses (prandial insulin)	units/day	From baseline (week -12 to 0) to end of study (week 26-36)
Secondary	Change in daily insulin doses (total insulin)	units/day	From baseline (week -12 to 0) to end of study (week 26-36)
Secondary	Change in number of patient reported overall non-severe hypoglycaemic episodes	Number of 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)
Secondary	Change in number of patient reported nocturnal non-severe hypoglycaemic episodes	Number of 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)
Secondary	Change in number of patient reported severe hypoglycaemic episodes (overall)	Number of 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)
Secondary	Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options)	Number of participants per response option	After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)