China Research of IDEgAsp Treatment in Real-world Clinica... | NCT05221580

ID	Type	Description	Link
U1111-1238-6960	Other Identifier	World Health Organization (WHO)

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2022Actual

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Jan 12, 2022

First Submission Date that Met QC Criteria

Feb 2, 2022

First Posted Date

Feb 3, 2022Actual

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 13, 2024

Last Update Posted Date

Jun 14, 2024Actual

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 this study is to collect information on how Ryzodeg® works in real-world patients.

Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment

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

887Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Real-world adult population of Chinese patients with T2DM		Ryzodec as per local clinical practise	Drug: Ryzodeg®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ryzodeg®	Drug	Patients will be treated with commercially available Ryzodeg® in a prefilled device (FlexTouch®) or in a penfill according to the label and routine clinical practice at the discretion of the treating physician

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	Percentage point	From baseline (week 0) to end of study (week 20 to 32)

Secondary Outcomes

Measure	Description	Time Frame
HbA1c less than 7 percent (Yes/No)	Percentage of patients	At the end of study (week 20 to 32)
HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No)

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 Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on the approved Ryzodeg® label in China and independently from the decision to include the patient in this study.
Male or female, age above or equal to 18 years at the time of signing informed consent.
Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 20 weeks prior to Treatment Initiation Visit (Visit 1).
Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1).

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.
Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Real-world adult population with type 2 diabetes in China.

Sampling Method

Non-Probability Sample

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

Facility	Status	City	State	ZIP	Country	Contacts
NIS-The Second People's Hospital of Hefei		Hefei	Anhui	230012	China
NIS-Beijing Hospital

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

http://novonordisk-trials.com

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