GOAL: A Research Study Looking at Long Term Blood Sugar Control in People With Type 2 Diabetes Treated With Xultophy® in Local Clinical Practice in Japan.

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04838743
Collaborator
(none)
244
Enrollment
31
Locations
16
Anticipated Duration (Months)
7.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect information on how Xultophy® works with other oral anti diabetic medication in patients with type 2 diabetes.

Participants will get Xultophy® as prescribed by the study doctor. The study will last for about 26 weeks. Participants will be asked questions about health and diabetes treatment and lab tests as part of normal doctor's appointment.

Condition or DiseaseIntervention/TreatmentPhase

Study Design

Study Type:
Observational
Anticipated Enrollment :
244 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Non-interventional, Single-arm, Multicentre, Prospective Study Investigating the Glycaemic Control and Treatment Pattern Associated With the Use of Xultophy® (IDegLira) in a Real-world Adult Population With Type 2 Diabetes Mellitus in Japan. GOAL (Glycaemic Outcome Assessment IDegLira) Study
Actual Study Start Date :
Apr 23, 2021
Anticipated Primary Completion Date :
Aug 22, 2022
Anticipated Study Completion Date :
Aug 22, 2022

Arms and Interventions

ArmIntervention/Treatment
IDegLira

Real-world adult population with type 2 diabetes mellitus in Japan.

Drug: IDegLira
Patients will be treated with commercially available Xultophy® (IDegLira) in a pre-filled pen injector (FlexTouch®) at the discretion of the treating physician in accordance with the Xultophy® label in Japan. The decision to initiate treatment with Xultophy® is at the treating physician's discretion according to the approved Xultophy® label in Japan and independent from the decision to include the patient in the study.

Outcome Measures

Primary Outcome Measures

  1. Change in local laboratory measured HbA1c (Glycated haemoglobin ) [From baseline (Visit 1) to 26 weeks (Visit 3)]

    % point

Secondary Outcome Measures

  1. Change in local laboratory measured FPG (Fasting plasma glucose ) [From baseline (Visit 1) to 26 weeks (Visit 3)]

    mg/dL

  2. Number of patient-reported non-severe hypoglycaemic after initiation of treatment with Xultophy® [From baseline (Visit 1) to 26 weeks (Visit 3)]

    Count of episodes Non-severe hypoglycaemia: Defined as an episode with patient reported symptoms and/or self-measured plasma glucose value below 3.9 mmol/L (70 mg/dL). episodes

  3. Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy® [From baseline (Visit 1) to 26 weeks (Visit 3)]

    Count of episodes Severe hypoglycaemia: Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action episodes

  4. Change in concomitant OAD(s) (Oral antidiabetic drugs ) including change in number, class, and frequency of concomitant OAD(s), after initiation of treatment of Xultophy® (Yes/No) [From baseline (Visit 1) to 26 weeks (Visit 3)]

    Count of patients

  5. Change in daily dose of Xultophy® [From baseline (Visit 1) to 26 weeks (Visit 3)]

    Dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 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 Xultophy® has been made by the patient/Legally Acceptable Representative (LAR) 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 20 years at the time of signing informed consent

  • Diagnosed with T2DM (Type 2 diabetes mellitus ) above or equal to 180 days prior to initiation of Xultophy® treatment.

  • Treated with any oral anti-hyperglycaemic medication(s), except for oral GLP-1 RAs, for at least 60 days prior to initiation of Xultophy® treatment.

  • Available and documented HbA1c value less or equal to 12 weeks prior to initiation of Xultophy® treatment.

Exclusion Criteria:
  • Previous participation in this study. Participation is defined as having given informed consent in this study.

  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before prior to initiation of Xultophy® (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening.).

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 60 days prior to initiation of Xultophy® treatment. However, short term insulin treatment for a maximum of 14 days prior to initiation of Xultophy® treatment is allowed, as is prior insulin treatment for gestational diabetes.

  • Previous treatment with Xultophy®.

  • Female who is known pregnant, breast-feeding or intends to become pregnant.

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

  • Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Xultophy® label in Japan.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteAichiJapan468-0009
2Novo Nordisk Investigational SiteAsahikawa-shi, HokkaidoJapan070-0054
3Novo Nordisk Investigational SiteBunkyo-ku, TokyoJapan113-8603
4Novo Nordisk Investigational SiteChibaJapan299-1144
5Novo Nordisk Investigational SiteChuo-ku, TokyoJapan103-0002
6Novo Nordisk Investigational SiteEhimeJapan790-0026
7Novo Nordisk Investigational SiteFukuoka-shi, FukuokaJapan819-0006
8Novo Nordisk Investigational SiteGunmaJapan373-0036
9Novo Nordisk Investigational SiteKanagawaJapan235-0045
10Novo Nordisk Investigational SiteKanagawaJapan253-0042
11Novo Nordisk Investigational SiteKitakyusyu-shi, FukuokaJapan802-0974
12Novo Nordisk Investigational SiteKochi-shi, KochiJapan780-0082
13Novo Nordisk Investigational SiteKumamotoJapan862-0976
14Novo Nordisk Investigational SiteKurashiki-shi, OkayamaJapan701-0192
15Novo Nordisk Investigational SiteMinato-kuJapan105-8471
16Novo Nordisk Investigational SiteNaka-shiJapan311 0113
17Novo Nordisk Investigational SiteOita-shi, OitaJapan870-0955
18Novo Nordisk Investigational SiteOita-shi, OitaJapan8700831
19Novo Nordisk Investigational SiteOita-shiJapan870 0039
20Novo Nordisk Investigational SiteOitaJapan879-7301
21Novo Nordisk Investigational SiteOkawa-shi, FukuokaJapan831-0016
22Novo Nordisk Investigational SiteOsaka-shiJapan553-0023
23Novo Nordisk Investigational SiteOsakaJapan553-0003
24Novo Nordisk Investigational SiteOsakaJapan591-8006
25Novo Nordisk Investigational SiteSaga-shi, SagaJapan8400054
26Novo Nordisk Investigational SiteShizuoka-shi, ShizuokaJapan424-0853
27Novo Nordisk Investigational SiteShizuokaJapan420-0853
28Novo Nordisk Investigational SiteTamana-shi, KumamotoJapan865 0016
29Novo Nordisk Investigational SiteTochigiJapan323-0022
30Novo Nordisk Investigational SiteTokyoJapan190-0023
31Novo Nordisk Investigational SiteTokyoJapan206-0033

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 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:
NCT04838743
Other Study ID Numbers:
  • NN9068-4743
  • U1111-1253-2025
  • jRCT1051210008
First Posted:
Apr 9, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 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 Oct 7, 2021