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

Locations

Anticipated Duration (Months)

6.3

Patients Per Site

0.3

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 Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: IDegLira

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 :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 22, 2023

Arms and Interventions

Arm	Intervention/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.

Arm

Intervention/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

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

Secondary Outcome Measures

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

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

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Aichi	Japan	468-0009
2	Novo Nordisk Investigational Site	Arakawa-ku, Tokyo	Japan	116-0012
3	Novo Nordisk Investigational Site	Asahikawa-shi, Hokkaido	Japan	070-0054
4	Novo Nordisk Investigational Site	Bunkyo-ku, Tokyo	Japan	113-8603
5	Novo Nordisk Investigational Site	Chiba	Japan	299-1144
6	Novo Nordisk Investigational Site	Chuo-ku, Tokyo	Japan	103-0002
7	Novo Nordisk Investigational Site	Ehime	Japan	790-0026
8	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka	Japan	819-0006
9	Novo Nordisk Investigational Site	Gunma	Japan	373-0036
10	Novo Nordisk Investigational Site	Kanagawa	Japan	235-0045
11	Novo Nordisk Investigational Site	Kanagawa	Japan	253-0042
12	Novo Nordisk Investigational Site	Kawagoe-shi, Saitama	Japan	350-0851
13	Novo Nordisk Investigational Site	Kisarazu-shi, Chiba	Japan	292-0038
14	Novo Nordisk Investigational Site	Kitakyusyu-shi, Fukuoka	Japan	802-0974
15	Novo Nordisk Investigational Site	Kochi-shi, Kochi	Japan	780-0082
16	Novo Nordisk Investigational Site	Koriyama-shi	Japan	963 8851
17	Novo Nordisk Investigational Site	Kumamoto	Japan	862-0976
18	Novo Nordisk Investigational Site	Kurashiki-shi, Okayama	Japan	701-0192
19	Novo Nordisk Investigational Site	Minato-ku	Japan	105-8471
20	Novo Nordisk Investigational Site	Miyazaki	Japan	880-0034
21	Novo Nordisk Investigational Site	Nagoya-shi, Aichi	Japan	456-0058
22	Novo Nordisk Investigational Site	Naka-shi	Japan	311 0113
23	Novo Nordisk Investigational Site	Oita-shi, Oita	Japan	870-0955
24	Novo Nordisk Investigational Site	Oita-shi, Oita	Japan	8700831
25	Novo Nordisk Investigational Site	Oita-shi	Japan	870 0039
26	Novo Nordisk Investigational Site	Oita	Japan	879-7301
27	Novo Nordisk Investigational Site	Okawa-shi, Fukuoka	Japan	831-0016
28	Novo Nordisk Investigational Site	Osaka-shi	Japan	553-0023
29	Novo Nordisk Investigational Site	Osaka	Japan	553-0003
30	Novo Nordisk Investigational Site	Osaka	Japan	591-8006
31	Novo Nordisk Investigational Site	Saga-shi, Saga	Japan	8400054
32	Novo Nordisk Investigational Site	Shizuoka-shi, Shizuoka	Japan	424-0853
33	Novo Nordisk Investigational Site	Shizuoka	Japan	420-0853
34	Novo Nordisk Investigational Site	Soka-shi, Saitama	Japan	340-0034
35	Novo Nordisk Investigational Site	Tamana-shi, Kumamoto	Japan	865 0016
36	Novo Nordisk Investigational Site	Tochigi	Japan	323-0022
37	Novo Nordisk Investigational Site	Tokyo	Japan	190-0023
38	Novo Nordisk Investigational Site	Tokyo	Japan	206-0033
39	Novo Nordisk Investigational Site	Yamato-shi, Kanagawa	Japan	242-0004

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:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Xultophy

Study Results

No Results Posted as of Mar 22, 2022