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OpenTrials
Completed

NCT Number: NCT05221580

China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NIS-The Second People's Hospital of Hefei, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

    Percentage point

Secondary outcomes

  1. HbA1c less than 7 percent (Yes/No)

    Time frame: 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)

    Time frame: 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)

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

    mmol/L

  4. Change in insulin dose (total, basal, prandial)

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

    units/day

  5. Change in body weight

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

    Kg

  6. Patient preference compared to previous treatment

    Time frame: 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))

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: CREATE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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