General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus
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
2 other identifiers
observational
630
1 country
80
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedStudy Start
First participant enrolled
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
April 9, 2026
April 1, 2026
2.2 years
January 29, 2025
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Adverse Reactions (ARs)
Measured as number of events.
From baseline (week 0) to end of study (week 52)
Secondary Outcomes (6)
Number of Adverse Events (AEs)
From baseline (week 0) to end of study (week 52)
Number of Serious Adverse Events (SAEs)
From baseline (week 0) to end of study (week 52)
Number of Serious Adverse Reactions (SARs)
From baseline (week 0) to end of study (week 52)
Change in Glycosylated Haemoglobin (HbA1c)
From baseline (week 0) to end of study (week 52)
Change in Fasting Plasma Glucose (FPG)
From baseline (week 0) to end of study (week 52)
- +1 more secondary outcomes
Study Arms (1)
Awiqli
Participants with diabetes mellitus will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
Interventions
Participants will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (80)
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, 862-0976, Japan
Abe Diabetes Clinic_Internal Medicine
Ōita, Oita, Japan, 870 0039, Japan
Miyachi Clinic
Aichi, 448-0852, Japan
Clinic Tosaki
Aichi, 468-0009, Japan
Fukuoka Naika Clinic_Internal Medicine
Aichi, 470-0126, Japan
Uenishi Internal Medicine Clinic
Aichi, 485-0044, Japan
Ichinomiyanishi Hospital
Aichi, 494-0001, Japan
Ohisama Clinic_Aomori
Aomori, 030-0823, Japan
Kakizaki Tonyobyo Naika Clinic
Aomori, 038-0011, Japan
Chiba Central Medical Center
Chiba, 264-0017, Japan
Shinmatsudo Central General Hospital_Diabetes and Endocrinology
Chiba, 270-0034, Japan
Kimitsu Chuo Hospital_Diabetology and Endocrinology
Chiba, 292-0822, Japan
Soyokaze CardioVascular Medicine and Diabetes Care
Ehime, 790-0026, Japan
Kyushu Rosai Hospital_Diabetes and Metabolism
Fukuoka, 800-0296, Japan
Kitakyushu Municipal Medical Center_Endocrinology and Diabetes
Fukuoka, 802-8561, Japan
Steel Memorial Yawata Hospital_Diabetes Internal Medicine
Fukuoka, 805-8508, Japan
Okada Naika Clinic
Fukuoka, 812-0053, Japan
Clinic Masae Minami
Fukuoka, 815-0071, Japan
Ito Naika Clinic_Internal Medicine
Fukuoka, 818-0024, Japan
Gifu University Hospital_Diabetes and Endocrinology
Gifu, 501-1194, Japan
Shimizu Naika
Gunma, 370-0069, Japan
Takasawa Diabetes Clinic
Hokkaido, 041-0821, Japan
Ito Hiroshi Naika Tonyobyonaika Clinic
Hokkaido, 064-0824, Japan
Takabe Diabetes Clinic
Hyogogoken, 670-0837, Japan
Kagayaki Diabetes and Endocrinology Clinic Sannomiya_Diabetes Internal Medicine
Hyōgo, 651-0086, Japan
Matsuda Diabetes Clinic
Hyōgo, 651-2135, Japan
Hyogo Prefectural Awaji Medical Center_Diabetes and Endocrinology
Hyōgo, 656-0021, Japan
Ushiku Aiwa General Hospital_Diabetes and Metabolism
Ibaraki, 300-1296, Japan
Mitoyo General Hospital_Internal Medicine
Kagawa, 769-1695, Japan
Tempozan Clinic of Internal Medicine
Kagoshima-shi, Kagoshima, 890-0061, Japan
Teikyo Univ.HP, Mizonokuchi_Fourth Internal Medicine
Kanagawa, 213-8507, Japan
Yokohama Rosai Hospital_Diabetes and Endocrinology
Kanagawa, 222-0036, Japan
Hiyoshi Clinic_Diabetes Internal Medicine
Kanagawa, 223-0062, Japan
H.E.C Science Clinic
Kanagawa, 235-0045, Japan
Kikuchi Naika Clinic_Kanagawa
Kanagawa, 236-0033, Japan
Hotaruno hakuyukai Medical Corporation of Japan
Kisarazu-shi, Chiba, 292-0038, Japan
Kumamoto University Hospital, Diabetes, Metabo and Endo
Kumamoto-shi, Kumamoto, 860-0811, Japan
Kamiuchi Naika Clinic
Kyoto, 604-8416, Japan
Kyoto University Hospital_Department of Diabetes, Endocr
Kyoto-shi, Kyoto, 606-8507, Japan
MG Clinic
Mie, 516-0035, Japan
Kanno Naika_Internal Medicine
Mitaka-shi, Tokyo, 181-0013, Japan
Heiwadai Hospital_Diabetes and Internal Medicine
Miyazaki, 880-0034, Japan
Asama General Hospital_Diabetology
Nagano, 385-8558, Japan
Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism
Nagano, 399-4511, Japan
Sasebo City General Hospital_Diabetes and Endocrinology
Nagasaki, 857-8511, Japan
Kuriya Clinic_Diabetes and Internal Medicine
Nagasaki, 859-3242, Japan
Minagawa Clinic Internal Medicine
Niigata, 942-0052, Japan
Kitakamiekimae Naika Clinic
Numakunai, 024-0061, Japan
Okayama Medical Center_Diabetes and Endocrinology
Okayama, 701-1192, Japan
Chibana Clinic
Okinawa, 904-2143, Japan
Osaka General Hospital of West Japan Railway Company_Diabetes and Metabolism
Osaka, 545-0053, Japan
Kansai Electric Power Hospital_Center for Diabetes
Osaka, 553-0003, Japan
Osaka General Medical Center_Diabetes and Endocrinology
Osaka, 558-8558, Japan
Ogawa Clinic
Osaka, 581-0869, Japan
Matsuda Gastroenterology and Diabetes Clinic
Osaka, 591-8006, Japan
Okamoto Clinic for Diabetes and Endocrinology
Ōita, 879-7301, Japan
Imari Arita Kyoritsu Hospital_Internal Medicine
Saga, 849-4193, Japan
Higashisakado Clinic_Diabetes Internal Medicine
Saitama, 350-0205, Japan
Matsudakai Tsurugaya Clinic, Internal medicine
Sendai-shi, Miyagi, 983-0824, Japan
Nagahama City Hospital_Nephrology and Metabolism
Shiga, 526-8580, Japan
Yamauchi Naika_Internal Medicine
Shimane, 694-0041, Japan
Yamane Hospital
Shimane, 697-0062, Japan
Kikuchi Medical Clinic
Shizuoka, 430-0802, Japan
Nagasaki Hospital_Internal Medicine
Tochigi, 326-0053, Japan
Kudanzaka Hospital_Internal Medicine
Tokyo, 102-0074, Japan
Aoi Clinic_Diabetes and Internal Medicine
Tokyo, 105-0004, Japan
The Jikei University Hospital Dept of Diabetes, Metabolic
Tokyo, 105-8471, Japan
Okamoto Naika Clinic
Tokyo, 135-0042, Japan
Matsuura Clinic
Tokyo, 150-0013, Japan
Mishuku Hospital_Endocrinology and Metabolism
Tokyo, 153-0051, Japan
Tokyo Kyosai Hospital_Diabetes and Endocrinology
Tokyo, 153-8934, Japan
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers_Diabetes and Endocrinology
Tokyo, 158-8531, Japan
Tokyo Women's Medical University_Diabetes and Metabolism
Tokyo, 162-0054, Japan
National Center for Global Health and Medicine_Diabetes and Endocrinology
Tokyo, 162-8655, Japan
KAWASAKI internal medicine clinic & Diabetic
Tokyo, 178-0063, Japan
Tamacenter Clinic Mirai
Tokyo, 206-0033, Japan
Honda Clinic_Internal Medicine
Tottori, 683-0012, Japan
Tohoku Central Hospital_Diabetes Internal Medicine
Yamagata, 990-8510, Japan
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, 242-0004, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2025
First Posted
February 4, 2025
Study Start
May 30, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com