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NCT Number: NCT01859598

Observational Registry for Basal Insulin Treatment Study (ORBIT)

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haidian hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline and 6 months

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

  2. the Change of Hypoglycemia During Follow-up.

    Time frame: baseline and 6 months

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

Secondary outcomes

  1. the FPG Change From Visit 1 to Visit 3

    Time frame: baseline and 6 months

    the FPG change = the FPG level at visit 1- the FPG level at visit 3

  2. the FPG Control Rate at Visit 3

    Time frame: 6 months

    the percentage of patients who had the FPG level <7.0 mmol/L at visit 3

  3. Overall Weight Gain From Visit 1 to Visit 3

    Time frame: baseline and 6 months

    the weight gain= the mean weight at visit1 - the mean weight at visit 3

Sponsors and collaborators

Lead sponsor

The George Institute for Global Health, China

Other

Collaborators

  • Chinese Diabetes Society

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 22, 2013
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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