NCT01525693

Brief Summary

This is a study to gain better understanding on how those patients who are newly diagnosed with type 2 diabetes are treated and monitored. The study will record information such as type of therapy, therapeutic outcomes, and patients' satisfaction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2012

Enrollment Period

1.5 years

First QC Date

February 1, 2012

Last Update Submit

February 13, 2013

Conditions

Keywords

diabetesdiabeticshigh glucoseChinese patients

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of this study is the overall proportion of patients whose HbA1c is less than 6.5%, measured at the end of one year follow up.

    12 months

Secondary Outcomes (2)

  • The proportions of patients receiving various regimen, and the duration of each regimen

    12 months

  • The clinical effectiveness of each regimen measured by the proportion of patients reaching the target glycemic control

    12 months

Study Arms (1)

Diagnosed within 6 months

No (test) intervention to be adminisitered

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects seen at outpatient clinics of tier 1, 2, and 3 hospitals across the 6 major geographic regions

You may not qualify if:

  • Patients who are not willing or not able to return to the same hospital for follow up visits every 3 months for one year after enrollment (e.g. do no reside locally)
  • Patients who are participating in another interventional clinical trials
  • Patients who are not willing to sign informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

People's Hospital of Peking University

Beijing, China

Location

Xijing Hospital

Xi'an, China

Location

Related Publications (2)

  • Luo Y, Wu H, Liao X, Zhao T, Cui N, Li A, Sun X, Zhang P, Huang Y, Zhang X, Yin H, Ji L. A Guideline-Based Decision Tree Achieves Better Glucose Control with Less Hypoglycemia at 3 Months in Chinese Diabetic Patients. Diabetes Ther. 2021 Jul;12(7):1887-1899. doi: 10.1007/s13300-021-01075-1. Epub 2021 May 29.

  • Cai X, Hu D, Pan C, Li G, Lu J, Ji Q, Su B, Tian H, Qu S, Weng J, Zhang D, Xu J, Ji L. The risk factors of glycemic control, blood pressure control, lipid control in Chinese patients with newly diagnosed type 2 diabetes _ A nationwide prospective cohort study. Sci Rep. 2019 May 22;9(1):7709. doi: 10.1038/s41598-019-44169-4.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Linong Ji, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 3, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

February 15, 2013

Record last verified: 2012-02

Locations