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Diabetes Mellitus, Type 2CN-TREATNCT04227431

A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in China

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 56 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to collect information on how Tresiba® works in patients with type 2 diabetes in China. The study will be based on data already recorded in participants' medical records and no new tests or procedures are required as part of the study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin degludec
Type of treatment
Pill or oral medicine
How many people
938 participants
Where
56 sitesChina
Study dates
17 Jan 2020to 17 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diabetes Mellitus, Type 2 (T2D) patients, who had Tresiba® added to their previous Oral Anti-diabetic drugs (OADs) or were switched to Tresiba® treatment from any previous basal insulin based on the clinical judgement of the treating physician and were treated with Tresiba® for at least 20 weeks in routine clinical practice in China.

Who may be able to join

  • Signed informed consent Form (ICF) obtained before any study-related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female, aged at least 18 years at the time of signing the ICF.
  • Diagnosed with T2D.
  • Treated with any OAD(s) or basal insulin ± OAD(s), with or without prandial insulin for at least 20 weeks prior to treatment initiation with Tresiba®.
  • 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.
  • Treated with Tresiba® (with or without OADs, with or without prandial insulin) for at least 20 weeks and have at least one documented medical visit with HbA1c measurement in the first 20 weeks (plus/minus 8 weeks) after Tresiba® initiation. The patient may or may not be treated with Tresiba® at the time of patient selection to this study.
  • 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 [plus/minus 8 weeks] after Tresiba® treatment), and duration and type of insulin treatment (for insulin treated patients).

Who cannot join

  • Previous participation in this study. Participation is defined as having signed the ICF.
  • Participation (defined as randomisation) in a diabetes clinical trial of an approved or non-approved investigational medicinal product within 20 weeks prior to the treatment initiation with Tresiba® or during the first 28 weeks of treatment with Tresiba®.
  • Tresiba® not used in accordance with the local label.
  • Patients treated with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® (short-term [equal to or less than 14 days] treatment with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® is allowed).
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

China56 sites

  • NIS-Cangzhou Central Hospital

    Cangzhou, Hebei, 061001

  • NIS-No.2 Hospital Affiliated to Jilin University

    Changchun, Jilin, 130041

  • NIS-The 1st Affi. Hosp. of Changchun Univer. of Chinese Medi

    Changchun, Jilin, 150040

  • NIS-Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shaanxi, 046000

  • NIS-Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213003

  • NIS-No.9 People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400700

  • NIS-The Third Affiliated Hospital of Chongqing Medical Univ.

    Chongqing, Chongqing Municipality, 401120

  • NIS-Dali First People's Hospital

    Dali, Yunnan, 671000

  • NIS-Dingzhou People's Hospital

    Dingzhou, Hebei, 073099

  • NIS-Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • NIS-The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

  • NIS-Hainan Provincial Hospital of TCM

    Haikou, Hainan, 570203

  • NIS-Haerbin 1st Hospital

    Harbin, Heilongjiang, 150000

  • NIS-The Second Affiliated Hospital of Harbin Medical Univ.

    Harbin, Heilongjiang, 150001

  • NIS-Heilongjiang Provincial Hospital

    Harbin, Heilongjiang, 150036

  • NIS-The Second Hospital of Anhui Medical Hospital

    Hefei, Anhui, 230601

  • NIS-Huizhou Third People's Hospital

    Huizhou, Guangdong, 516002

  • NIS-The No.2 Hospital affiliated to Guizhou Medical college

    Kaili, 556000

  • NIS-The Second Affiliated Hospital of Kunming Medical Univ.

    Kunming, Yunnan, 650101

  • NIS-Kunshan 1st People's Hospital

    Kunshan, Jiangsu, 215300

  • NIS-CNPC Central Hospital

    Langfang, Hebei, 065000

  • NIS-Langfang people's Hospital

    Langfang, Hebei, 065000

  • NIS-People's Hospital of Gansu Province

    Lanzhou, Gansu, 730000

  • NIS-People's Hospital of Linxia, Gansu

    Linxia, Gansu, 731100

  • NIS-Nanjing Jiangbei Hospital

    Nanjing, Jiangsu, 210000

  • NIS-The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008

  • NIS-Zhong Da Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • NIS-Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211199

  • NIS-Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • NIS-Qingyuan People's Hospital

    Qingyuan, Guangdong, 511518

  • NIS-People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110016

  • NIS-Shenyang Central Hospital

    Shenyang, Liaoning, 110024

  • NIS-The Affiliated Hospital of Liaoning TCM University

    Shenyang, Liaoning, 110032

  • NIS-The 4th Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110084

  • NIS-Shenzhen Futian District People's Hospital

    Shenzhen, Guangdong, 518033

  • NIS-The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

  • NIS-General Hospital of Shenzhen University

    Shenzhen, Guangdong, 518055

  • NIS-No.1 Hospital affiliated to Shihezi Medical College

    Shihezi, Xinjiang, 832008

  • NIS-The 3rd Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • NIS-General Hospital of Shiyan Dongfeng Group

    Shiyan, Hubei, 442000

  • NIS-The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • NIS-Zhangjiagang Hospital of Traditional Chinese Medicine

    Suzhou, Jiangsu, 215600

  • NIS-Second Hospital of Shanxi Medical University

    Taiyuan, Shaanxi, 030001

  • NIS-Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030012

  • NIS-Xinjiang Traditional Chinese Medicine Hospital

    Ürümqi, Xinjiang, 510170

  • NIS-The 5th Affiliated Hospital of Xinjiang Medical Univ.

    Ürümqi, Xinjiang, 830000

  • NIS-The 2nd Affiliated Hospital of Xinjiang Medical Univer.

    Ürümqi, Xinjiang, 830028

  • NIS-The First Affiliated Hospital of Xinjiang Medical Univ.

    Ürümqi, Xinjiang, 830054

  • NIS-Weifang People's Hospital

    Weifang, Shandong, 261000

  • NIS-Wuxi 2nd People's Hospital

    Wuxi, Jiangsu, 214000

  • NIS-Affiliated Hospital of Shanxi TCM Colleage

    Xianyang, Shaanxi, 712000

  • NIS- Qinghai Red Cross Hospital

    Xining, Qinghai, 810099

  • NIS-People's Hospital of Qinghai Province

    Xining, 810007

  • NIS-Affiliated Hospital of Shanxi Yanan Medical Colleage

    Yan’an, Shaanxi, 716000

  • NIS-People's Hospital of Henan Province

    Zhengzhou, Hainan, 450003

  • NIS-The First Affiliated Hospital, Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: The Effect of Tresiba® (Insulin Degludec) in Type 2 Diabetes Patients in Real World Clinical Practice in China - Noninterventional, Retrospective Chart Review Study

The purpose of the study is to collect information on how Tresiba® works in patients with type 2 diabetes in China. The study will be based on data already recorded in participants' medical records and no new tests or procedures are required as part of the study. This study does not affect participants' current diabetes treatment. The study will look at data recorded in participants' medical records for approximately the last year. After signing the informed consent form, no further activities will be required from the participants.

Being tested
Insulin degludec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin degludecOther

    Participants have been treated with Tresiba® (insulin degludec) for at least 20 weeks before entering the study. The study will be based on data already recorded in participants' medical records for approximately the last year and no new tests or procedures are required as part of the study.

Study groups in NCT04227431
Study groupRoleWhat they receive
Tresiba®A broad real world type 2 diabetes (T2D) patient population in China, treated with oral anti-diabetic drugs (OAD(s)) or basal insulin prior to treatment initiation with Tresiba®
Receives: Other: Insulin degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycosylated haemoglobin (HbA1c)

    Percent point

    Measured: Week 0, week 20

Secondary outcomes (7)

  1. Change in laboratory-measured fasting plasma glucose (FPG)

    mmol/L

    Measured: From baseline (week 0) to end of study (week 20)

  2. Change in self-measured fasting plasma glucose (SMPG)

    mmol/L

    Measured: From baseline (week 0) to end of study (week 20)

  3. Change in daily insulin doses (total, basal, prandial)

    Units/day

    Measured: From baseline (week 0) to end of study (week 20)

  4. Change in rates of hypoglycaemic episodes (number of episodes/patient years) (overall, nonsevere, severe, nocturnal) before and after add on of/switch to Tresiba®

    Count. All recorded events will be captured in the 20 weeks prior to treatment initiation with Tresiba (week 0) and 20 weeks after treatments initiation with Tresiba (week 20)

    Measured: From baseline (week 0) to end of study (week 20)

  5. Patient having at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after add-on of/switch to Tresiba® (Yes/no)

    Count

    Measured: From baseline (week 0) to end of study (week 20)

  6. Change in number of concomitant non-insulin anti-diabetic drugs before and after add-on/switch to Tresiba®

    Count. All recorded recorded concomitant non-insulin antidiabetic drugs will be captured in the 20 weeks prior to treatment initiation with Tresiba (week 0) and 20 weeks after treatments initiation with Tresiba (week 20)

    Measured: From baseline (week 0) to end of study (week 20)

  7. Reason(s) for starting Tresiba®, at time of switch/add-on, if available

    Free text listing

    Measured: At baseline (week 20)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start17 Jan 2020
  3. Primary completion17 Jul 2021
  4. Study completion17 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
938 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04227431
Sponsor's protocol ID
NN1250-4442
Other IDs
U1111-1208-5180
Acronym
CN-TREAT
Status last verified
Mar 2024
First submitted
10 Jan 2020
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Wang W, Chang X, Lehrskov LL, Li L, Nordentoft M, Quan J, Sha Y, Zhong X, Yang C, Zhu D. Insulin Degludec in People with Type 2 Diabetes in China: A Non-interventional, Retrospective Chart Review Study (CN-TREAT). Diabetes Ther. 2024 Mar;15(3):725-739. doi: 10.1007/s13300-024-01533-6. Epub 2024 Mar 5.

    PubMed 38438707

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 56 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycosylated haemoglobin (HbA1c) (time frame: Week 0, week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04227431, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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