Clinical trial NCT06807190: General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus
Official title: A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 630
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises patients who are diagnosed with diabetes mellitus and who agree to be treated with Awiqli after consultation with their physician independently from the decision to participate in this study.

Brief summary: The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.


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 Awiqli 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 with no age limitation.
* Diagnosis of diabetes mellitus. There is no limitation for type of diabetes mellitus and prior treatment for diabetes mellitus.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Treatment with any investigational drug within 30 days prior to enrolment into the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Contraindication described in Japanese package insert.
* Participants showing hypoglycaemic symptoms.
* Participants with a history of hypersensitivity to any ingredients of this drug.

Primary outcomes:
measure: Number of Adverse Reactions (ARs)
timeFrame: From baseline (week 0) to end of study (week 52)
Secondary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: From baseline (week 0) to end of study (week 52)
measure: Number of Serious Adverse Events (SAEs)
timeFrame: From baseline (week 0) to end of study (week 52)
measure: Number of Serious Adverse Reactions (SARs)
timeFrame: From baseline (week 0) to end of study (week 52)
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of study (week 52)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline (week 0) to end of study (week 52)
measure: Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL)
timeFrame: From baseline (week 0) to end of study (week 52)
Other outcomes:
Locations:
city: Koriyama-shi
country: Japan
facility: Seino Internal Medicine Clinic
state: Fukushima, Japan
city: Kumamoto-shi
country: Japan
facility: Jinnouchi Hospital
state: Kumamoto, Japan
city: Aichi
country: Japan
facility: Miyachi Clinic
city: Aichi
country: Japan
facility: Clinic Tosaki
city: Aichi
country: Japan
facility: Uenishi Internal Medicine Clinic
city: Aomori
country: Japan
facility: Ohisama Clinic_Aomori
city: Aomori
country: Japan
facility: Kakizaki Tonyobyo Naika Clinic
city: Chiba
country: Japan
facility: Chiba Central Medical Center
city: Chiba
country: Japan
facility: Kimitsu Chuo Hospital
city: Ehime
country: Japan
facility: Soyokaze CardioVascular Medicine and Diabetes Care
city: Fukuoka
country: Japan
facility: Clinic Masae Minami
city: Fukuoka
country: Japan
facility: Ito Naika Clinic_Internal Medicine
city: Hyogogoken
country: Japan
facility: Takabe Diabetes Clinic
city: Hyogo
country: Japan
facility: Kagayaki Diabetes and Endocrinology Clinic Sannomiya_Diabetes Internal Medicine
city: Hyogo
country: Japan
facility: Matsuda Diabetes Clinic
city: Hyogo
country: Japan
facility: Hyogo Prefectural Awaji Medical Center_Diabetes and Endocrinology
city: Iwate
country: Japan
facility: Kitakamiekimae Naika Clinic
city: Kagawa
country: Japan
facility: Mitoyo General Hospital_Internal Medicine
city: Kanagawa
country: Japan
facility: Yokohama Rosai Hospital_Diabetes and Endocrinology
city: Kanagawa
country: Japan
facility: Kikuchi Naika Clinic_Kanagawa
city: Kisarazu-shi, Chiba
country: Japan
facility: Hotaruno hakuyukai Medical Corporation of Japan
city: Kyoto-shi, Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mitaka-shi, Tokyo
country: Japan
facility: Kanno Naika_Internal Medicine
city: Nagano
country: Japan
facility: Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism
city: Niigata
country: Japan
facility: Minagawa Clinic Internal Medicine
city: Oita
country: Japan
facility: Okamoto Clinic for Diabetes and Endocrinology
city: Osaka
country: Japan
facility: Osaka General Hospital of West Japan Railway Company_Diabetes and Metabolism
city: Osaka
country: Japan
facility: Ogawa Clinic
city: Osaka
country: Japan
facility: Matsuda Gastroenterology and Diabetes Clinic
city: Saga
country: Japan
facility: Imari Arita Kyoritsu Hospital_Internal Medicine
city: Shimane
country: Japan
facility: Yamane Hospital
city: Shizuoka
country: Japan
facility: Kikuchi Medical Clinic
city: Tokyo
country: Japan
facility: Aoi Clinic_Diabetes and Internal Medicine
city: Tokyo
country: Japan
facility: Matsuura Clinic
city: Tokyo
country: Japan
facility: Mishuku Hospital
city: Tokyo
country: Japan
facility: Tokyo Kyosai Hospital_Diabetes and Endocrinology
city: Tokyo
country: Japan
facility: Kanto Central Hospital of the Mutual Aid Association of Public School Teachers_Diabetes and Endocrinology
city: Tokyo
country: Japan
facility: Tamacenter Clinic Mirai
city: Tottori
country: Japan
facility: Honda Clinic_Internal Medicine
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: