CREATE: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in China as Part of Local Clinical Practice

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05221580
• Collaborator: (none)
• Enrollment: 887
• Location: 1
• Anticipated Duration (Months): 26.3
• Patients Per Site Per Month: 33.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Ryzodeg®

Study Design

• Study Type: Observational
• Anticipated Enrollment: 887 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in China
• Actual Study Start Date: Mar 18, 2022
• Anticipated Primary Completion Date: May 28, 2024
• Anticipated Study Completion Date: May 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Real-world adult population of Chinese patients with T2DM Ryzodec as per local clinical practise	Drug: Ryzodeg®; 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

Outcome Measures

Primary Outcome Measures

1. Change in Glycosylated Haemoglobin (HbA1c) [From baseline (week 0) to end of study (week 20 to 32)]

   Percentage point

Secondary Outcome Measures

1. HbA1c less than 7 percent (Yes/No) [At the end of study (week 20 to 32)]

   Percentage of patients

2. HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No) [At the end of study (week 20 to 32) Hypoglycaemic episodes occurring within 4 weeks prior to end of study (week 20 to 32).]

   Percentage of patients

3. Change in Fasting Plasma Glucose (FPG) [From baseline (week 0) to end of study (week 20 to 32)]

   mmol/L

4. Change in insulin dose (total, basal, prandial) [From baseline (week 0) to end of study (week 20 to 32)]

   units/day

5. Change in body weight [From baseline (week 0) to end of study (week 20 to 32)]

   Kg

6. Patient preference compared to previous treatment [At baseline and end of study (week 20 to 32)]

   Percentage of patients who prefer to continue treatment with Ryzodeg® over previous treatment. Assessed by questionnaire

7. Treatment satisfaction questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQ)) [At baseline and end of study (week 20 to 32)]

   Score based on items 1, 4, 5, 6, 7 and 8. Range 0-36, where higher score means greater satisfaction (better outcome)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

2. 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.

3. Male or female, age above or equal to 18 years at the time of signing informed consent.

4. 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).

5. 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:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.

2. Treatment with any investigational drug within 30 days prior to enrolment into the study.

3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Beijing	Beijing	China	100005

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05221580
• Other Study ID Numbers: NN5401-4623; U1111-1238-6960
• First Posted: Feb 3, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin degludec, insulin aspart drug combination

Study Results

No Results Posted as of Jul 11, 2022