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CN-TREAT (Chinese TREsiba AudiT) The effectof Tresiba (insulin degludec) in type 2 diabetes patients in real world clinical practice in China - a case records based retrospective study

CN-TREAT (Chinese TREsiba AudiT) The effectof Tresiba (insulin degludec) in type 2 diabetes patients in real world clinical practice in China - a case records based retrospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026198
Enrollment
Unknown
Registered
2019-09-26
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

Case series:Nil

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 200 Years

Inclusion criteria

Inclusion criteria: For an eligible patient must meet all of inclusion criteria items: 1. Signed informed consent Form (ICF) obtained before any study-related activities. Studyrelated activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study; 2. Male or female, aged >18 years at the time of signing the ICF; 3. Diagnosed with T2D; 4. Treated with any OAD(s) or basal insulin +/-OAD(s), +/-prandial insulin for at least 20 weeks prior to treatment initiation with Tresiba; 5. The decision to initiate treatment with commercially available Tresiba 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; 6. Treated with Tresiba (+/- OADs, ±prandial insulin) for at least 20 weeks and have at least one documented medical visit with HbA1c measurement in the first 20 weeks (+/-8 weeks) after Tresiba initiation. The patient may or may not be treated with Tresiba at the time of patient selection to this study; 7. Minimum available data: age, weight, and sex at the time of Tresiba initiation, HbA1c (most recent value within 12 weeks prior to Tresiba? initiation and a value in the first 20 weeks [+/-8 weeks] after Tresiba? treatment), and duration and type of insulin treatment (for insulin treated patients). Note: If the patients have one variable with a missing value in minimum available data set, they will not be included.

Exclusion criteria

Exclusion criteria: 1. Previous participation in this study. Participation is defined as having signed the ICF; 2. Participation (defined as randomisation) in a diabetes clinical trial of an approved or nonapproved investigational medicinal product within 20 weeks prior to the treatment initiation with Tresiba? or during the first 28 weeks of treatment with Tresiba; 3. Tresiba not be used in accordance with the local label; 4. Patients treated with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba (short-term [<=14 days] treatment with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba? is allowed); 5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Countries

China

Contacts

Public ContactXia Jiang

Tianjin First Central Hospital

Jiangxia9698@163.com+86 13302119698

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026