General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus

April 3, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Aichi, Japan, 448-0852
        • Recruiting
        • Miyachi Clinic
      • Aichi, Japan, 468-0009
        • Recruiting
        • Clinic Tosaki
      • Aichi, Japan, 470-0126
        • Enrolling by invitation
        • Fukuoka Naika Clinic_Internal Medicine
      • Aichi, Japan, 485-0044
        • Recruiting
        • Uenishi Internal Medicine Clinic
      • Aichi, Japan, 494-0001
        • Enrolling by invitation
        • Ichinomiyanishi Hospital
      • Aomori, Japan, 030-0823
        • Enrolling by invitation
        • Ohisama Clinic_Aomori
      • Aomori, Japan, 038-0011
        • Recruiting
        • Kakizaki Tonyobyo Naika Clinic
      • Chiba, Japan, 264-0017
        • Enrolling by invitation
        • Chiba Central Medical Center
      • Chiba, Japan, 270-0034
        • Enrolling by invitation
        • Shinmatsudo Central General Hospital_Diabetes and Endocrinology
      • Chiba, Japan, 292-0822
        • Recruiting
        • Kimitsu Chuo Hospital_Diabetology and Endocrinology
      • Ehime, Japan, 790-0026
        • Enrolling by invitation
        • Soyokaze CardioVascular Medicine and Diabetes Care
      • Fukuoka, Japan, 815-0071
        • Recruiting
        • Clinic Masae Minami
      • Fukuoka, Japan, 800-0296
        • Enrolling by invitation
        • Kyushu Rosai Hospital_Diabetes and Metabolism
      • Fukuoka, Japan, 802-8561
        • Enrolling by invitation
        • Kitakyushu Municipal Medical Center_Endocrinology and Diabetes
      • Fukuoka, Japan, 805-8508
        • Enrolling by invitation
        • Steel Memorial Yawata Hospital_Diabetes Internal Medicine
      • Fukuoka, Japan, 812-0053
        • Enrolling by invitation
        • Okada Naika Clinic
      • Fukuoka, Japan, 818-0024
        • Recruiting
        • Ito Naika Clinic_Internal Medicine
      • Gifu, Japan, 501-1194
        • Enrolling by invitation
        • Gifu University Hospital_Diabetes and Endocrinology
      • Gunma, Japan, 370-0069
        • Enrolling by invitation
        • Shimizu Naika
      • Hokkaido, Japan, 041-0821
        • Enrolling by invitation
        • Takasawa Diabetes Clinic
      • Hokkaido, Japan, 064-0824
        • Enrolling by invitation
        • Ito Hiroshi Naika Tonyobyonaika Clinic
      • Hyogogoken, Japan, 670-0837
        • Enrolling by invitation
        • Takabe Diabetes Clinic
      • Hyōgo, Japan, 651-0086
        • Enrolling by invitation
        • Kagayaki Diabetes and Endocrinology Clinic Sannomiya_Diabetes Internal Medicine
      • Hyōgo, Japan, 656-0021
        • Enrolling by invitation
        • Hyogo Prefectural Awaji Medical Center_Diabetes and Endocrinology
      • Hyōgo, Japan, 651-2135
        • Recruiting
        • Matsuda Diabetes Clinic
      • Ibaraki, Japan, 300-1296
        • Enrolling by invitation
        • Ushiku Aiwa General Hospital_Diabetes and Metabolism
      • Kagawa, Japan, 769-1695
        • Enrolling by invitation
        • Mitoyo General Hospital_Internal Medicine
      • Kagoshima-shi, Kagoshima, Japan, 890-0061
        • Enrolling by invitation
        • Tempozan Clinic of Internal Medicine
      • Kanagawa, Japan, 222-0036
        • Enrolling by invitation
        • Yokohama Rosai Hospital_Diabetes and Endocrinology
      • Kanagawa, Japan, 213-8507
        • Enrolling by invitation
        • Teikyo Univ.HP, Mizonokuchi_Fourth Internal Medicine
      • Kanagawa, Japan, 223-0062
        • Enrolling by invitation
        • Hiyoshi Clinic_Diabetes Internal Medicine
      • Kanagawa, Japan, 235-0045
        • Enrolling by invitation
        • H.E.C Science Clinic
      • Kanagawa, Japan, 236-0033
        • Recruiting
        • Kikuchi Naika Clinic_Kanagawa
      • Kisarazu-shi, Chiba, Japan, 292-0038
        • Recruiting
        • Hotaruno hakuyukai Medical Corporation of Japan
      • Kumamoto-shi, Kumamoto, Japan, 860-0811
        • Enrolling by invitation
        • Kumamoto University Hospital, Diabetes, Metabo and Endo
      • Kyoto, Japan, 604-8416
        • Enrolling by invitation
        • Kamiuchi Naika Clinic
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Enrolling by invitation
        • Kyoto University Hospital_Department of Diabetes, Endocr
      • Mie, Japan, 516-0035
        • Enrolling by invitation
        • MG Clinic
      • Mitaka-shi, Tokyo, Japan, 181-0013
        • Recruiting
        • Kanno Naika_Internal Medicine
      • Miyazaki, Japan, 880-0034
        • Enrolling by invitation
        • Heiwadai Hospital_Diabetes and Internal Medicine
      • Nagano, Japan, 399-4511
        • Enrolling by invitation
        • Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism
      • Nagano, Japan, 385-8558
        • Enrolling by invitation
        • Asama General Hospital_Diabetology
      • Nagasaki, Japan, 857-8511
        • Enrolling by invitation
        • Sasebo City General Hospital_Diabetes and Endocrinology
      • Nagasaki, Japan, 859-3242
        • Enrolling by invitation
        • Kuriya Clinic_Diabetes and Internal Medicine
      • Niigata, Japan, 942-0052
        • Enrolling by invitation
        • Minagawa Clinic Internal Medicine
      • Numakunai, Japan, 024-0061
        • Recruiting
        • Kitakamiekimae Naika Clinic
      • Okayama, Japan, 701-1192
        • Enrolling by invitation
        • Okayama Medical Center_Diabetes and Endocrinology
      • Okinawa, Japan, 904-2143
        • Enrolling by invitation
        • Chibana Clinic
      • Osaka, Japan, 545-0053
        • Recruiting
        • Osaka General Hospital of West Japan Railway Company_Diabetes and Metabolism
      • Osaka, Japan, 553-0003
        • Enrolling by invitation
        • Kansai Electric Power Hospital_Center for Diabetes
      • Osaka, Japan, 558-8558
        • Enrolling by invitation
        • Osaka General Medical Center_Diabetes and Endocrinology
      • Osaka, Japan, 581-0869
        • Recruiting
        • Ogawa Clinic
      • Osaka, Japan, 591-8006
        • Recruiting
        • Matsuda Gastroenterology and Diabetes Clinic
      • Saga, Japan, 849-4193
        • Recruiting
        • Imari Arita Kyoritsu Hospital_Internal Medicine
      • Saitama, Japan, 350-0205
        • Enrolling by invitation
        • Higashisakado Clinic_Diabetes Internal Medicine
      • Sendai-shi, Miyagi, Japan, 983-0824
        • Enrolling by invitation
        • Matsudakai Tsurugaya Clinic, Internal medicine
      • Shiga, Japan, 526-8580
        • Enrolling by invitation
        • Nagahama City Hospital_Nephrology and Metabolism
      • Shimane, Japan, 694-0041
        • Enrolling by invitation
        • Yamauchi Naika_Internal Medicine
      • Shimane, Japan, 697-0062
        • Recruiting
        • Yamane Hospital
      • Shizuoka, Japan, 430-0802
        • Recruiting
        • Kikuchi Medical Clinic
      • Tochigi, Japan, 326-0053
        • Enrolling by invitation
        • Nagasaki Hospital_Internal Medicine
      • Tokyo, Japan, 105-0004
        • Enrolling by invitation
        • Aoi Clinic_Diabetes and Internal Medicine
      • Tokyo, Japan, 158-8531
        • Enrolling by invitation
        • Kanto Central Hospital of the Mutual Aid Association of Public School Teachers_Diabetes and Endocrinology
      • Tokyo, Japan, 102-0074
        • Enrolling by invitation
        • Kudanzaka Hospital_Internal Medicine
      • Tokyo, Japan, 105-8471
        • Enrolling by invitation
        • The Jikei University Hospital Dept of Diabetes, Metabolic
      • Tokyo, Japan, 135-0042
        • Enrolling by invitation
        • Okamoto Naika Clinic
      • Tokyo, Japan, 150-0013
        • Recruiting
        • Matsuura Clinic
      • Tokyo, Japan, 153-0051
        • Enrolling by invitation
        • Mishuku Hospital_Endocrinology and Metabolism
      • Tokyo, Japan, 153-8934
        • Recruiting
        • Tokyo Kyosai Hospital_Diabetes and Endocrinology
      • Tokyo, Japan, 162-0054
        • Enrolling by invitation
        • Tokyo Women's Medical University_Diabetes and Metabolism
      • Tokyo, Japan, 162-8655
        • Enrolling by invitation
        • National Center for Global Health and Medicine_Diabetes and Endocrinology
      • Tokyo, Japan, 178-0063
        • Enrolling by invitation
        • KAWASAKI internal medicine clinic & Diabetic
      • Tokyo, Japan, 206-0033
        • Recruiting
        • Tamacenter Clinic Mirai
      • Tottori, Japan, 683-0012
        • Recruiting
        • Honda Clinic_Internal Medicine
      • Yamagata, Japan, 990-8510
        • Not yet recruiting
        • Tohoku Central Hospital_Diabetes Internal Medicine
      • Yamato-shi, Kanagawa, Japan, 242-0004
        • Enrolling by invitation
        • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
      • Ōita, Japan, 879-7301
        • Recruiting
        • Okamoto Clinic for Diabetes and Endocrinology
    • Fukushima, Japan
      • Koriyama-shi, Fukushima, Fukushima, Japan, Japan, 963-8851
        • Recruiting
        • Seino Internal Medicine Clinic_Internal medicine
    • Kumamoto, Japan
      • Kumamoto, Kumamoto, Japan, Japan, 862-0976
        • Recruiting
        • Jinnouchi Hospital_Internal Medicine
    • Oita, Japan
      • Ōita, Oita, Japan, Japan, 870 0039
        • Enrolling by invitation
        • Abe Diabetes Clinic_Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Awiqli
Participants with diabetes mellitus will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
Drug: Insulin Icodec
Participants will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
Other Names:
  • Awiqli

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Reactions (ARs)
Time Frame: From baseline (week 0) to end of study (week 52)
Measured as number of events.
From baseline (week 0) to end of study (week 52)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events (AEs)
Time Frame: From baseline (week 0) to end of study (week 52)
Measured as number of events.
From baseline (week 0) to end of study (week 52)
Number of Serious Adverse Events (SAEs)
Time Frame: From baseline (week 0) to end of study (week 52)
Measured as number of events.
From baseline (week 0) to end of study (week 52)
Number of Serious Adverse Reactions (SARs)
Time Frame: From baseline (week 0) to end of study (week 52)
Measured as number of events.
From baseline (week 0) to end of study (week 52)
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to end of study (week 52)
Measured as percentage (%) point of HbA1c.
From baseline (week 0) to end of study (week 52)
Change in Fasting Plasma Glucose (FPG)
Time Frame: From baseline (week 0) to end of study (week 52)
Measured as milligrams per decilitre (mg/dL).
From baseline (week 0) to end of study (week 52)
Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL)
Time Frame: From baseline (week 0) to end of study (week 52)
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).
From baseline (week 0) to end of study (week 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-7680
  • U1111-1286-0463 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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