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Completed

NCT Number: NCT00806936

Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects

This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study
  • The selection of the subjects will be at the discretion of the individual investigator

Exclusion criteria

  • Known or suspected allergy to trial product(s) or related products
  • Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
  • Subjects who previously enrolled in this study
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • The receipt of any investigational product within 3 months prior to this trial

Treatment and study plan

human insulin

Drug

Any kind of human insulin administered at the discretion of the physician

insulin analogue

Drug

Any kind of insulin analogue administered at the discretion of the physician

Primary outcomes

  1. Percentage of patients achieving HbA1c below 7.0%

    Time frame: at 16 weeks

Secondary outcomes

  1. HbA1c change from baseline

    Time frame: at 16 weeks

  2. Incidence of major, minor and symptoms only hypoglycaemic episodes

    Time frame: at 16 weeks

  3. Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)

    Time frame: at baseline and at 16 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More Oral Antidiabetic Drugs in China

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 11, 2008
Registry last updated
Oct 28, 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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