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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04315688
Collaborator
(none)
494
40
16.1
12.4
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: insulin degludec

Study Design

Study Type:
Observational
Actual Enrollment :
494 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia
Actual Study Start Date :
Mar 30, 2020
Actual Primary Completion Date :
Aug 2, 2021
Actual Study Completion Date :
Aug 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Tresiba®

Patients with type 2 diabetes

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.

Outcome Measures

Primary Outcome Measures

  1. Change in laboratory measured glycated haemoglobin (HbA1c) (% point) [From baseline (week -12 to 0) to end of study (week 26-36)]

    % point

  2. Change in laboratory measured HbA1c (mmol/mol) [From baseline (week -12 to 0) to end of study (week 26-36)]

    mmol/mol

Secondary Outcome Measures

  1. Change in laboratory measured fasting plasma glucose (FPG) [From baseline (week -12 to 0) to end of study (week 26-36)]

    mg/dL

  2. Change in laboratory measured FPG [From baseline (week -12 to 0) to end of study (week 26-36)]

    mmol/L

  3. Change in daily insulin doses (basal insulin) [From baseline (week -12 to 0) to end of study (week 26-36)]

    units/day

  4. Change in daily insulin doses (prandial insulin) [From baseline (week -12 to 0) to end of study (week 26-36)]

    units/day

  5. Change in daily insulin doses (total insulin) [From baseline (week -12 to 0) to end of study (week 26-36)]

    units/day

  6. 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

  7. 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

  8. 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

  9. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Alushta Russian Federation 298500
2 Novo Nordisk Investigational Site Belogorsk Russian Federation 297600
3 Novo Nordisk Investigational Site Bryansk Russian Federation 242610
4 Novo Nordisk Investigational Site Chapaevsk Russian Federation 446100
5 Novo Nordisk Investigational Site Chelyabinsk Russian Federation 454048
6 Novo Nordisk Investigational Site Dyurtyuli Russian Federation 452320
7 Novo Nordisk Investigational Site Elista Russian Federation 358000
8 Novo Nordisk Investigational Site Ivanovo Russian Federation 153012
9 Novo Nordisk Investigational Site Kaluga Russian Federation 248002
10 Novo Nordisk Investigational Site Kazan Russian Federation 420073
11 Novo Nordisk Investigational Site Krasnodar Russian Federation 350000
12 Novo Nordisk Investigational Site Krasnoyarsk Russian Federation 660021
13 Novo Nordisk Investigational Site Krasnoyarsk Russian Federation 660062
14 Novo Nordisk Investigational Site Lipetsk Russian Federation 398043
15 Novo Nordisk Investigational Site Lyskovo Russian Federation 606210
16 Novo Nordisk Investigational Site Magnitogorsk Russian Federation 455016
17 Novo Nordisk Investigational Site Moscow Region, Dolgoprudny Russian Federation 141707
18 Novo Nordisk Investigational Site Moscow Russian Federation 111401
19 Novo Nordisk Investigational Site Moscow Russian Federation 117036
20 Novo Nordisk Investigational Site Moscow Russian Federation 129226
21 Novo Nordisk Investigational Site N. Novgorod Russian Federation 603155
22 Novo Nordisk Investigational Site Odintsovo, Moscow Region Russian Federation 143003
23 Novo Nordisk Investigational Site Penza Russian Federation 440039
24 Novo Nordisk Investigational Site Penza Russian Federation 440066
25 Novo Nordisk Investigational Site Rostov-on-Don Russian Federation 344004
26 Novo Nordisk Investigational Site Saint-Peterburg Russian Federation 195256
27 Novo Nordisk Investigational Site Saint-Peterburg Russian Federation 199004
28 Novo Nordisk Investigational Site Saint-Petersburg Russian Federation 194358
29 Novo Nordisk Investigational Site Samara Russian Federation 443111
30 Novo Nordisk Investigational Site Saratov Russian Federation 410005
31 Novo Nordisk Investigational Site Saratov Russian Federation 410033
32 Novo Nordisk Investigational Site Sergiev Posad Russian Federation 141300
33 Novo Nordisk Investigational Site Sevastopol Russian Federation 299011
34 Novo Nordisk Investigational Site Sovetskiy Russian Federation 297200
35 Novo Nordisk Investigational Site St. Petersburg Russian Federation 193231
36 Novo Nordisk Investigational Site Syktyvkar Russian Federation 167981
37 Novo Nordisk Investigational Site Tula Russian Federation 300035
38 Novo Nordisk Investigational Site Ufa Russian Federation 450038
39 Novo Nordisk Investigational Site Voskresensk Russian Federation 140203
40 Novo Nordisk Investigational Site Vyksa Russian Federation 607060

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04315688
Other Study ID Numbers:
  • NN1250-4589
  • U1111-1236-4887
First Posted:
Mar 19, 2020
Last Update Posted:
Aug 23, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2021