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.

Diabetes Mellitus, Type 2 Clinical Trial

— GOAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838743
• Other study ID #: NN9068-4743
• Secondary ID: U1111-1253-2025j
• Status: Completed
• Start date: April 23, 2021
• Est. completion date: October 26, 2022

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 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 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Japan	TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology	Aichi
Japan	Kumanomae Nishimura Internal Medical Clinic	Arakawa-ku, Tokyo
Japan	Yoshida Hospital	Asahikawa-shi, Hokkaido
Japan	Nippon Medical School Hospital, Diabetes,Metabology,Endocrin	Bunkyo-ku, Tokyo
Japan	Gengendo Kimitsu Hospital	Chiba
Japan	The Institute of Medical Science, Asahi Life Foundation	Chuo-ku, Tokyo
Japan	Soyokaze CardioVascular Medicine and Diabetes Care	Ehime
Japan	Kawada Clinic	Gunma
Japan	Chigasaki Municipal Hospital	Kanagawa
Japan	H.E.C Science Clinic	Kanagawa
Japan	Hotaruno hakuyukai Medical Corporation of Japan	Kisarazu-shi, Chiba
Japan	Gendai Clinic	Kitakyusyu-shi, Fukuoka
Japan	Ohisama Clinic	Kochi-shi, Kochi
Japan	Seino Internal Medicine Clinic	Koriyama-shi	Fukushima, Japan
Japan	Jinnouchi Hospital	Kumamoto-shi	Kumamoto, Japan
Japan	Kawasaki Medical School Hospital, Diabetes, Endo and Metabo	Kurashiki-shi, Okayama
Japan	The Jikei Medical University Hospital	Minato-ku
Japan	Heiwadai Hospital	Miyazaki-shi	Miyazaki, Japan
Japan	Naka Kinen Clinic	Naka-shi	Ibaraki, Japan
Japan	Okamoto Clinic for Diabetes and Endocrinology	Oita
Japan	Abe Diabetes Clinic_Internal Medicine	Oita-shi	Oita, Japan
Japan	Oita Endocrinology Diabetes Clinic	Oita-shi, Oita
Japan	Takagi hospital, Internal Medicine	Okawa-shi, Fukuoka
Japan	Matsuda Gastroenterology and Diabetes Clinic	Osaka
Japan	Nakajima Diabetes Clinic	Osaka-shi
Japan	Budounoki Clinic	Saga-shi, Saga
Japan	Japanese Red Cross Shizuoka Hospital	Shizuoka
Japan	Suruga Clinic	Shizuoka-shi, Shizuoka
Japan	Oyama East Clinic	Tochigi
Japan	Tsuruma Kaneshiro Diabetes Clinic	Yamato-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in local laboratory measured HbA1c (Glycated haemoglobin )	% point	From baseline (Visit 1) to 26 weeks (Visit 3)
Secondary	Change in local laboratory measured FPG (Fasting plasma glucose )	mg/dL	From baseline (Visit 1) to 26 weeks (Visit 3)
Secondary	Number of patient-reported non-severe hypoglycaemic after initiation of treatment with Xultophy®	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	From baseline (Visit 1) to 26 weeks (Visit 3)
Secondary	Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy®	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	From baseline (Visit 1) to 26 weeks (Visit 3)
Secondary	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)	Count of patients	From baseline (Visit 1) to 26 weeks (Visit 3)
Secondary	Change in daily dose of Xultophy®	Dose	From baseline (Visit 1) to 26 weeks (Visit 3)