Clinical trial NCT04838743: 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.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 244
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Real-world adult population with type 2 diabetes mellitus in Japan

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.


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 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.

Primary outcomes:
measure: Change in local laboratory measured HbA1c (Glycated haemoglobin )
timeFrame: From baseline (Visit 1) to 26 weeks (Visit 3)
Secondary outcomes:
measure: Change in local laboratory measured FPG (Fasting plasma glucose )
timeFrame: From baseline (Visit 1) to 26 weeks (Visit 3)
measure: Number of patient-reported non-severe hypoglycaemic after initiation of treatment with Xultophy®
timeFrame: From baseline (Visit 1) to 26 weeks (Visit 3)
measure: Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy®
timeFrame: From baseline (Visit 1) to 26 weeks (Visit 3)
measure: 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)
timeFrame: From baseline (Visit 1) to 26 weeks (Visit 3)
measure: Change in daily dose of Xultophy®
timeFrame: From baseline (Visit 1) to 26 weeks (Visit 3)
Other outcomes:
Locations:
city: Koriyama-shi
country: Japan
facility: Seino Internal Medicine Clinic
state: Fukushima, Japan
city: Naka-shi
country: Japan
facility: Naka Kinen Clinic
state: Ibaraki, Japan
city: Yamato-shi
country: Japan
facility: Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Jinnouchi Hospital
state: Kumamoto, Japan
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki, Japan
city: Oita-shi
country: Japan
facility: Abe Diabetes Clinic_Internal Medicine
state: Oita, Japan
city: Aichi
country: Japan
facility: TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
city: Arakawa-ku, Tokyo
country: Japan
facility: Kumanomae Nishimura Internal Medical Clinic
city: Asahikawa-shi, Hokkaido
country: Japan
facility: Yoshida Hospital
city: Bunkyo-ku, Tokyo
country: Japan
facility: Nippon Medical School Hospital, Diabetes,Metabology,Endocrin
city: Chiba
country: Japan
facility: Gengendo Kimitsu Hospital
city: Chuo-ku, Tokyo
country: Japan
facility: The Institute of Medical Science, Asahi Life Foundation
city: Ehime
country: Japan
facility: Soyokaze CardioVascular Medicine and Diabetes Care
city: Gunma
country: Japan
facility: Kawada Clinic
city: Kanagawa
country: Japan
facility: H.E.C Science Clinic
city: Kanagawa
country: Japan
facility: Chigasaki Municipal Hospital
city: Kisarazu-shi, Chiba
country: Japan
facility: Hotaruno hakuyukai Medical Corporation of Japan
city: Kitakyusyu-shi, Fukuoka
country: Japan
facility: Gendai Clinic
city: Kochi-shi, Kochi
country: Japan
facility: Ohisama Clinic
city: Kurashiki-shi, Okayama
country: Japan
facility: Kawasaki Medical School Hospital, Diabetes, Endo and Metabo
city: Minato-ku
country: Japan
facility: The Jikei Medical University Hospital
city: Oita-shi, Oita
country: Japan
facility: Oita Endocrinology Diabetes Clinic
city: Oita
country: Japan
facility: Okamoto Clinic for Diabetes and Endocrinology
city: Okawa-shi, Fukuoka
country: Japan
facility: Takagi hospital, Internal Medicine
city: Osaka-shi
country: Japan
facility: Nakajima Diabetes Clinic
city: Osaka
country: Japan
facility: Matsuda Gastroenterology and Diabetes Clinic
city: Saga-shi, Saga
country: Japan
facility: Budounoki Clinic
city: Shizuoka-shi, Shizuoka
country: Japan
facility: Suruga Clinic
city: Shizuoka
country: Japan
facility: Japanese Red Cross Shizuoka Hospital
city: Tochigi
country: Japan
facility: Oyama East Clinic
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: