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

Last updated: June 12, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 1

Treatment

Insulin Icodec

Clinical Study ID

NCT06807190
NN1436-7680
U1111-1286-0463
  • All Genders

Study 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

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-relatedactivities are any procedure related to recording of data according to theprotocol).

  • The decision to initiate treatment with commercially available Awiqli has been madeby the patient/Legally Acceptable Representative (LAR) and the treating physicianbefore 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 mellitusand prior treatment for diabetes mellitus.

Exclusion

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having giveninformed consent in this study.

  • Treatment with any investigational drug within 30 days prior to enrolment into thestudy.

  • Mental incapacity, unwillingness or language barriers precluding adequateunderstanding 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 Design

Total Participants: 630
Treatment Group(s): 1
Primary Treatment: Insulin Icodec
Phase:
Study Start date:
April 15, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Seino Internal Medicine Clinic

    Koriyama-shi, Fukushima, Japan 963-8851
    Japan

    Site Not Available

  • Jinnouchi Hospital

    Kumamoto-shi, Kumamoto, Japan 862-0976
    Japan

    Site Not Available

  • Clinic Tosaki

    Aichi, 468-0009
    Japan

    Site Not Available

  • Miyachi Clinic

    Aichi, 448-0852
    Japan

    Site Not Available

  • Uenishi Internal Medicine Clinic

    Aichi, 485-0044
    Japan

    Site Not Available

  • Kakizaki Tonyobyo Naika Clinic

    Aomori, 038-0011
    Japan

    Site Not Available

  • Ohisama Clinic_Aomori

    Aomori, 030-0823
    Japan

    Site Not Available

  • Chiba Central Medical Center

    Chiba, 264-0017
    Japan

    Site Not Available

  • Kimitsu Chuo Hospital

    Chiba, 292-0822
    Japan

    Site Not Available

  • Soyokaze CardioVascular Medicine and Diabetes Care

    Ehime, 790-0026
    Japan

    Site Not Available

  • Clinic Masae Minami

    Fukuoka, 815-0071
    Japan

    Site Not Available

  • Ito Naika Clinic_Internal Medicine

    Fukuoka, 818-0024
    Japan

    Site Not Available

  • Hyogo Prefectural Awaji Medical Center_Diabetes and Endocrinology

    Hyogo, 656-0021
    Japan

    Site Not Available

  • Kagayaki Diabetes and Endocrinology Clinic Sannomiya_Diabetes Internal Medicine

    Hyogo, 651-0086
    Japan

    Site Not Available

  • Matsuda Diabetes Clinic

    Hyogo, 651-2135
    Japan

    Site Not Available

  • Takabe Diabetes Clinic

    Hyogogoken, 670-0837
    Japan

    Site Not Available

  • Kitakamiekimae Naika Clinic

    Iwate, 024-0061
    Japan

    Site Not Available

  • Mitoyo General Hospital_Internal Medicine

    Kagawa, 769-1695
    Japan

    Site Not Available

  • Kikuchi Naika Clinic_Kanagawa

    Kanagawa, 236-0033
    Japan

    Site Not Available

  • Yokohama Rosai Hospital_Diabetes and Endocrinology

    Kanagawa, 222-0036
    Japan

    Site Not Available

  • Hotaruno hakuyukai Medical Corporation of Japan

    Kisarazu-shi, Chiba, 292-0038
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto-shi, Kyoto, 606-8507
    Japan

    Site Not Available

  • Kanno Naika_Internal Medicine

    Mitaka-shi, Tokyo, 181-0013
    Japan

    Site Not Available

  • Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism

    Nagano, 399-4511
    Japan

    Site Not Available

  • Minagawa Clinic Internal Medicine

    Niigata, 942-0052
    Japan

    Site Not Available

  • Okamoto Clinic for Diabetes and Endocrinology

    Oita, 879-7301
    Japan

    Site Not Available

  • Matsuda Gastroenterology and Diabetes Clinic

    Osaka, 591-8006
    Japan

    Site Not Available

  • Ogawa Clinic

    Osaka, 581-0869
    Japan

    Site Not Available

  • Osaka General Hospital of West Japan Railway Company_Diabetes and Metabolism

    Osaka, 545-0053
    Japan

    Site Not Available

  • Imari Arita Kyoritsu Hospital_Internal Medicine

    Saga, 849-4193
    Japan

    Active - Recruiting

  • Yamane Hospital

    Shimane, 697-0062
    Japan

    Site Not Available

  • Kikuchi Medical Clinic

    Shizuoka, 430-0802
    Japan

    Site Not Available

  • Aoi Clinic_Diabetes and Internal Medicine

    Tokyo, 105-0004
    Japan

    Site Not Available

  • Kanto Central Hospital of the Mutual Aid Association of Public School Teachers_Diabetes and Endocrinology

    Tokyo, 158-8531
    Japan

    Site Not Available

  • Matsuura Clinic

    Tokyo, 150-0013
    Japan

    Site Not Available

  • Mishuku Hospital

    Tokyo, 153-0051
    Japan

    Site Not Available

  • Tamacenter Clinic Mirai

    Tokyo, 206-0033
    Japan

    Site Not Available

  • Tokyo Kyosai Hospital_Diabetes and Endocrinology

    Tokyo, 153-8934
    Japan

    Site Not Available

  • Honda Clinic_Internal Medicine

    Tottori, 683-0012
    Japan

    Site Not Available

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