Diabetes Mellitus, Type 1NCT06807190
General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 116 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin Icodec
- How many people
- 630 participants
- Where
- 116 sitesJapan
- Study dates
- 15 Apr 2025to 31 Jan 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
116 sites in 1 country. Contact the study team or a site near you to ask about taking part.
116 sites in 1 country
Japan116 sites, 116 recruiting
- Recruiting
Miyachi Clinic
Aichi, 448-0852
- Recruiting
Clinic Tosaki
Aichi, 468-0009
- Enrolling by invitation
Fukuoka Naika Clinic_Internal Medicine
Aichi, 470-0126
- Enrolling by invitation
Hattori Clinic Chiryu_Diabetes and Endocrinology
Aichi, 472-0053
- Recruiting
Uenishi Internal Medicine Clinic
Aichi, 485-0044
- Enrolling by invitation
Inazawa Municipal Hospital_Diabetes and Endocrinology
Aichi, 492-8510
- Enrolling by invitation
Ichinomiyanishi Hospital
Aichi, 494-0001
- Enrolling by invitation
Ohisama Clinic_Aomori
Aomori, 030-0823
- Recruiting
Kakizaki Tonyobyo Naika Clinic
Aomori, 038-0011
- Enrolling by invitation
Chiba Central Medical Center
Chiba, 264-0017
- Enrolling by invitation
Shinmatsudo Central General Hospital_Diabetes and Endocrinology
Chiba, 270-0034
- Recruiting
Kimitsu Chuo Hospital_Diabetology and Endocrinology
Chiba, 292-0822
- Not yet recruiting
Hasegawa Medicine Clinic, Internal medicine
Chitose, Hokkaido, 066-0032
- Enrolling by invitation
Soyokaze CardioVascular Medicine and Diabetes Care
Ehime, 790-0026
- Enrolling by invitation
Kyushu Rosai Hospital_Diabetes and Metabolism
Fukuoka, 800-0296
- Enrolling by invitation
Kokura Memorial Hospital_Diabetes and Endocrinology
Fukuoka, 802-8555
- Enrolling by invitation
Kitakyushu Municipal Medical Center_Endocrinology and Diabetes
Fukuoka, 802-8561
- Enrolling by invitation
Steel Memorial Yawata Hospital_Diabetes Internal Medicine
Fukuoka, 805-8508
- Enrolling by invitation
Okada Naika Clinic
Fukuoka, 812-0053
- Enrolling by invitation
Fukuoka Kieikai Hospital_Diabetes and obesity centre
Fukuoka, 813-0044
- Recruiting
Clinic Masae Minami
Fukuoka, 815-0071
- Recruiting
Ito Naika Clinic_Internal Medicine
Fukuoka, 818-0024
- Enrolling by invitation
Tanaka Naika Clinic_Internal Medicine
Fukuoka, 830-0023
- Enrolling by invitation
Gifu University Hospital_Diabetes and Endocrinology
Gifu, 501-1194
- Enrolling by invitation
Asano Naika
Gifu, 504-0829
- Enrolling by invitation
Shimizu Naika
Gunma, 370-0069
- Enrolling by invitation
Gunma University Hospital_Endocrinology and Diabetes
Gunma, 371-8511
- Enrolling by invitation
Murakami Memorial Hospital_Diabetes Internal Medicine
Hiroshima, 722-0014
- Enrolling by invitation
Kurihara Naika
Hokkaido, 004-0053
- Enrolling by invitation
Takasawa Diabetes Clinic
Hokkaido, 041-0821
- Enrolling by invitation
Ito Hiroshi Naika Tonyobyonaika Clinic
Hokkaido, 064-0824
- Enrolling by invitation
Yoshimura Tonyobyo Clinic
Hokkaido, 068-0021
- Enrolling by invitation
Kagetsu Clinic
Hokkaido, 073-1105
- Enrolling by invitation
Kagayaki Diabetes and Endocrinology Clinic Sannomiya_Diabetes Internal Medicine
Hyōgo, 651-0086
- Recruiting
Matsuda Diabetes Clinic
Hyōgo, 651-2135
- Enrolling by invitation
Hyogo Prefectural Awaji Medical Center_Diabetes and Endocrinology
Hyōgo, 656-0021
- Enrolling by invitation
Takabe Diabetes Clinic
Hyogogoken, 670-0837
- Enrolling by invitation
Ushiku Aiwa General Hospital_Diabetes and Metabolism
Ibaraki, 300-1296
- Enrolling by invitation
Itabashi Diabetes and Dermatology Medical Clinic
Ibaraki, 306-0232
- Enrolling by invitation
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
- Enrolling by invitation
Mitoyo General Hospital_Internal Medicine
Kagawa, 769-1695
- Enrolling by invitation
Tempozan Clinic of Internal Medicine
Kagoshima-shi, Kagoshima, 890-0061
- Enrolling by invitation
Teikyo Univ.HP, Mizonokuchi_Fourth Internal Medicine
Kanagawa, 213-8507
- Enrolling by invitation
Yokohama Rosai Hospital_Diabetes and Endocrinology
Kanagawa, 222-0036
- Enrolling by invitation
Hiyoshi Clinic_Diabetes Internal Medicine
Kanagawa, 223-0062
- Enrolling by invitation
H.E.C Science Clinic_Internal Medicine, Diabetes
Kanagawa, 235-0045
- Recruiting
Kikuchi Naika Clinic_Kanagawa
Kanagawa, 236-0033
- Enrolling by invitation
Shonanisehara Clinic_Internal Medicine
Kanagawa, 259-1114
- Enrolling by invitation
Takeda Clinic
Kanagawa, 259-1131
- Enrolling by invitation
Tokai University Hospital_Nephrology, Endocrinology and Metabolism
Kanagawa, 259-1193
- Recruiting
Hotaruno hakuyukai Medical Corporation of Japan
Kisarazu-shi, Chiba, 292-0038
- Recruiting
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851
- Recruiting
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, 862-0976
- Enrolling by invitation
Kumamoto University Hospital, Diabetes, Metabo and Endo
Kumamoto-shi, Kumamoto, 860-0811
- Enrolling by invitation
Kamiuchi Naika Clinic
Kyoto, 604-8416
- Enrolling by invitation
Kyoto University Hospital_Department of Diabetes, Endocr
Kyoto-shi, Kyoto, 606-8507
- Enrolling by invitation
Mie National Hospital_Internal Medicine
Mie, 514-0125
- Enrolling by invitation
MG Clinic
Mie, 516-0035
- Enrolling by invitation
Japanese Red Cross Ise Hospital_Diabetes and Metabolism
Mie, 516-8512
- Recruiting
Kanno Naika_Internal Medicine
Mitaka-shi, Tokyo, 181-0013
- Enrolling by invitation
Heiwadai Hospital_Diabetes and Internal Medicine
Miyazaki, 880-0034
- Enrolling by invitation
Ato internal medicine clinic, internal medicine
Muroran-shi, Hokkaido, 050-0073
- Enrolling by invitation
Asama General Hospital_Diabetology
Nagano, 385-8558
- Enrolling by invitation
Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism
Nagano, 399-4511
- Enrolling by invitation
Sasebo City General Hospital_Diabetes and Endocrinology
Nagasaki, 857-8511
- Enrolling by invitation
Kuriya Clinic_Diabetes and Internal Medicine
Nagasaki, 859-3242
- Enrolling by invitation
Minagawa Clinic Internal Medicine
Niigata, 942-0052
- Enrolling by invitation
Niigata Diabetes Clinic_Diabetes and Endocrinology
Niigata, 950-1101
- Recruiting
Kitakamiekimae Naika Clinic
Numakunai, 024-0061
- Recruiting
Okamoto Clinic for Diabetes and Endocrinology
Ōita, 879-7301
- Enrolling by invitation
Abe Diabetes Clinic_Internal Medicine
Oita-shi, Oita,, Japan, 870 0039
- Enrolling by invitation
Okayama Medical Center_Diabetes and Endocrinology
Okayama, 701-1192
- Enrolling by invitation
Chibana Clinic
Okinawa, 904-2143
- Recruiting
Osaka General Hospital of West Japan Railway Company_Diabetes and Metabolism
Osaka, 545-0053
- Enrolling by invitation
Kansai Electric Power Hospital_Center for Diabetes
Osaka, 553-0003
- Enrolling by invitation
Osaka General Medical Center_Diabetes and Endocrinology
Osaka, 558-8558
- Enrolling by invitation
Takatsuki General Hospital_Diabetes and Endocrinology
Osaka, 569-1192
- Enrolling by invitation
Kansai Medical University Medical Center_Cardiology and Endocrinology and Metabolism
Osaka, 570-8507
- Recruiting
Ogawa Clinic
Osaka, 581-0869
- Recruiting
Matsuda Gastroenterology and Diabetes Clinic_Internal Medicine
Osaka, 591-8006
- Enrolling by invitation
Japan Organization of Occupational Health and Safety Osaka Rosai Hospital_Diabetes Internal Medicine
Osaka, 5918025
- Enrolling by invitation
Saga Chuo Public Hospital_Diabetes Internal Medicine
Saga, 846-0012
- Recruiting
Imari Arita Kyoritsu Hospital_Internal Medicine
Saga, 849-4193
- Enrolling by invitation
Saitama Medical Center_Diabetes and Endocrinology
Saitama, 330-0074
- Enrolling by invitation
Japanese Red Cross Saitama Hospital_Diabetes and Endocrinology
Saitama, 330-8553
- Enrolling by invitation
Higashisakado Clinic_Diabetes Internal Medicine
Saitama, 350-0205
- Enrolling by invitation
Asano Clinic
Saitama, 350-0851
- Enrolling by invitation
Matsudakai Tsurugaya Clinic, Internal medicine
Sendai-shi, Miyagi, 983-0824
- Enrolling by invitation
Nagahama City Hospital_Nephrology and Metabolism
Shiga, 526-8580
- Enrolling by invitation
Yamauchi Naika_Internal Medicine
Shimane, 694-0041
- Recruiting
Yamane Hospital
Shimane, 697-0062
- Enrolling by invitation
Juntendo University Shizuoka Hospital_Diabetes and Endocrinology
Shizuoka, 410-2295
- Recruiting
Kikuchi Medical Clinic
Shizuoka, 430-0802
- Enrolling by invitation
Higashi Diabetes and Cardiovascular Clinic, Internal
Tamana-shi, Kumamoto, 865 0016
- Enrolling by invitation
Oyama East Clinic_Internal Medicine
Tochigi, 323-0022
- Enrolling by invitation
Nagasaki Hospital_Internal Medicine
Tochigi, 326-0053
- Enrolling by invitation
Ooshima Clinic
Tokushima, 770-0022
- Enrolling by invitation
Kudanzaka Hospital_Internal Medicine
Tokyo, 102-0074
- Enrolling by invitation
Aoi Clinic_Diabetes and Internal Medicine
Tokyo, 105-0004
- Enrolling by invitation
The Jikei University Hospital Dept of Diabetes, Metabolic
Tokyo, 105-8471
- Enrolling by invitation
Okamoto Naika Clinic
Tokyo, 135-0042
- Recruiting
Matsuura Clinic
Tokyo, 150-0013
- Enrolling by invitation
Mishuku Hospital_Endocrinology and Metabolism
Tokyo, 153-0051
- Recruiting
Tokyo Kyosai Hospital_Diabetes and Endocrinology
Tokyo, 153-8934
- Enrolling by invitation
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers_Diabetes and Endocrinology
Tokyo, 158-8531
- Enrolling by invitation
Tokyo Women's Medical University_Diabetes and Metabolism
Tokyo, 162-0054
- Enrolling by invitation
National Center for Global Health and Medicine_Diabetes and Endocrinology
Tokyo, 162-8655
- Enrolling by invitation
KAWASAKI internal medicine clinic & Diabetic
Tokyo, 178-0063
- Enrolling by invitation
Tokai University Hachioji Hospital_Neph.& Endocrinology,Metab.
Tokyo, 192-0032
- Recruiting
Tamacenter Clinic Mirai
Tokyo, 206-0033
- Recruiting
Honda Clinic_Internal Medicine
Tottori, 683-0012
- Enrolling by invitation
Wakayama Medical Univercity Hospital_Diabetes and Endocrinology
Wakayama, 641-8510
- Not yet recruiting
Tohoku Central Hospital_Diabetes Internal Medicine
Yamagata, 990-8510
- Enrolling by invitation
Kouchi Iin
Yamagata, 996-0035
- Enrolling by invitation
Kudamatsu Central Hospital_Internal Medicine
Yamaguchi, 744-0005
- Enrolling by invitation
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, 242-0004
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin Icodec
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin IcodecDrug
Also called Awiqli
Participants will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Awiqli | Participants with diabetes mellitus will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician. Receives: Drug: Insulin Icodec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Reactions (ARs)
Measured as number of events.
Measured: From baseline (week 0) to end of study (week 52)
Secondary outcomes (6)
Number of Adverse Events (AEs)
Measured as number of events.
Measured: From baseline (week 0) to end of study (week 52)
Number of Serious Adverse Events (SAEs)
Measured as number of events.
Measured: From baseline (week 0) to end of study (week 52)
Number of Serious Adverse Reactions (SARs)
Measured as number of events.
Measured: From baseline (week 0) to end of study (week 52)
Change in Glycosylated Haemoglobin (HbA1c)
Measured as percentage (%) point of HbA1c.
Measured: From baseline (week 0) to end of study (week 52)
Change in Fasting Plasma Glucose (FPG)
Measured as milligrams per decilitre (mg/dL).
Measured: From baseline (week 0) to end of study (week 52)
Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL)
DTR-QOL is a Japanese questionnaire assessing the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 questions and the response scale is a 7-point scale (1: strongly agree to 7: strongly disagree). The score of each item will be reversed so that "7: strongly disagree" represents the highest/desirable QOL. The total score, after simple addition of the item scores, is converted to 0 to 100 (best-case response is 100; worst case response is 0).
Measured: From baseline (week 0) to end of study (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start15 Apr 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807190
- Sponsor's protocol ID
- NN1436-7680
- Other IDs
- U1111-1286-0463
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com