NCT01859598

Brief Summary

The scientific use of basal insulin is of great help to individuals and the government. However, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in China. This study is to evaluate the use of first basal insulin in China patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (OADs) from the naturalistic clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19,894

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 12, 2016

Completed
Last Updated

October 12, 2016

Status Verified

February 1, 2016

Enrollment Period

2.5 years

First QC Date

April 13, 2012

Results QC Date

February 15, 2016

Last Update Submit

August 17, 2016

Conditions

Diabetes

Keywords

diabetesbasal insulineffectiveness and safetyoral antidiabetic drugsreal world clinical practice

Outcome Measures

Primary Outcomes (2)

  • To Assess the Change in HbA1c During the 6 Months Follow-up.

    • Change of HbA1c from baseline to the end-point (6 month).

    Baseline and 6 months

  • the Change of Hypoglycemia During Follow-up.

    •The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)

    baseline and 6 months

Secondary Outcomes (3)

  • the FPG Change From Visit 1 to Visit 3

    baseline and 6 months

  • the FPG Control Rate at Visit 3

    6 months

  • Overall Weight Gain From Visit 1 to Visit 3

    baseline and 6 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients meet the following criteria, either from in-patient or out-patient department, will have chance to be enrolled in this study.

You may qualify if:

  • years old
  • Type 2 diabetic patients
  • Recently tested HbA1c \>=7% at the same site within 3 months
  • Being suggested by physician to start basal insulin (BI) treatment
  • Willing to start and having been prescribed BI treatment
  • Willing to join the registry study and sign the informed consent

You may not qualify if:

  • Diagnosed with type 1 diabetes
  • Received any type of insulin in the last 2 years (except for the intermittent use of insulin of less than 1 month each time)
  • With any severe health problem, or any other situation judged by the investigator, that is difficult for the 6 months follow-up
  • Current or planned pregnant, lactating women
  • Involved in other clinical trial simultaneously or at most 1 month before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haidian hospital

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • 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.

    PMID: 34050897DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

The characteristics of patients receiving different treatment modalities may not be consistent, and the use of Basal Insulin (BI) depended on individual choices of doctors and patients, resulting in differences in insulin usage among various regions.

Results Point of Contact

Title
Pro. Linong Ji
Organization
The George Institute for Global Health at Peking University Health Science Center
jiln@bjmu.edu.cn
82800577

Study Officials

  • Linong Ji, Prof.

    The George Institute for Global Health, China

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

May 22, 2013

Study Start

December 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 12, 2016

Results First Posted

October 12, 2016

Record last verified: 2016-02

Locations

CN(2)