General Use-results Surveillance With Awiqli in Patients... | NCT06807190

ID	Type	Description	Link
U1111-1286-0463	Other Identifier	World Health Organization (WHO)

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2025Actual

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Jan 31, 2028Estimated

First Submitted Date

Jan 29, 2025

First Submission Date that Met QC Criteria

Jan 29, 2025

First Posted Date

Feb 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2026

Last Update Posted Date

Jun 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

630Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin Icodec	Drug	Participants will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.	Awiqli

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of Adverse Events (AEs)	Measured as number of events.	From baseline (week 0) to end of study (week 52)
Number of Serious Adverse Events (SAEs)	Measured as number of events.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Novo Nordisk	Contact	(+1) 866-867-7178		clinicaltrials@novonordisk.com

Overall Officials

Name	Affiliation	Role
Clinical Transparency (dept. 2834)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seino Internal Medicine Clinic_Internal medicine	Enrolling by invitation	Koriyama-shi, Fukushima	Fukushima, Japan	963-8851	Japan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://novonordisk-trials.com

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases