Observational Registry for Basal Insulin Treatment Study (ORBIT)

Diabetes Clinical Trial

Official title:

A Prospective, Observational Registry Study Focusing on the Real World Use, Effectiveness and Safety of Initial Basal Insulin Regimen in Type 2 Diabetic Patients Uncontrolled by Oral Antidiabetic Drugs in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01859598
• Other study ID #: ORBIT
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2012
• Last updated: May 20, 2013
• Start date: December 2011
• Est. completion date: October 2014

Study information

• Verified date: May 2013
• Source: The George Institute for Global Health, China
• Contact: Puhong Zhang, PhD
• Phone: +86 10 8280 0476-512
• Email: zpuhong[@]georgeinstitute.org.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This is a 6-month multicentre, observational, prospective, registry study. About 200 hospitals from different parts of China will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12 months period.

The study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. The project will probably last for about 18 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years old

• Type 2 diabetic patients

• Taking OADs before inclusion

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
China	Haidian hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	Chinese Diabetes Society

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the change in HbA1c during the 6 months follow-up.	Change of HbA1c from baseline to the end-point (6 month).; Percentage of patients reaching the target of HbA1c <7.0% at the end-point.	6 month	No
Primary	To assess the change in frequency of hypoglycemia and other adverse events during the 6 months follow-up.	The number of severe adverse events during the 6 months follow-up.; Change of cumulative number of severe hypoglycaemic episodes during 3 months before baseline and the end-point.; Change of cumulative number of hypoglycaemic episodes during 1 month before baseline and the end-point.; Change of body weight from baseline to the end-point.	6 months	Yes
Secondary	Compare the HbA1c change during the follow-up among the commonly used basal insulins (NPH, Glargine and Detemir insulin)	Compare the HbA1c change and HbA1c control rate among the three commonly used basal insulins.	6 month	No
Secondary	Compare the incidence of adverse events during the follow-up among the commonly used basal insulins (NPH, Glargine and Detemir insulin)	Compare the following indicators among the three commonly used basal insulins: The number of severe adverse events during the 6 months follow-up.; Change of cumulative number of severe hypoglycaemic episodes during 3 months before baseline and the end-point.; Change of cumulative number of hypoglycaemic episodes during 1 month before baseline and the end-point.; Change of body weight from baseline to the end-point.	6 months	Yes
Secondary	To explore the factors that influence the glycemic control and safety of basal insulin regimens	To explore the influence factors of HbA1c control and adverse events by univariate and multivariate analysis.; Dependent variables: change in HbA1c, hypoglycemia and body weight; Independent/categorical variables: regions, level of hospital, glycemic level at baseline, type of basal insulin at baseline, dose of insulin at the endpoint, combination therapy, self monitoring of blood glucose, lifestyle, cost of drug, etc; Covariates: demographic characteristic	6 months	Yes
Secondary	To explore the impact of BI regimens to the quality of life	To describe and compare the change in quality of life before and after initial basal insulin regimens	6 months	No