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NCT Number: NCT00715780

Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
  • Insulin naive
  • Poor glycaemic control on OADs and decided by the physician to start insulin therapy

Exclusion criteria

  • Type 1 diabetes patients
  • Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
  • Patients with a hypersensitivity to insulin or to any of the excipients
  • Patient groups not approved in the product label

Treatment and study plan

soluble human insulin

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Other names: Actrapid®

biphasic human insulin

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

insulin NPH

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

insulin aspart

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

biphasic insulin aspart

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

insulin detemir

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Primary outcomes

  1. Incidence of major hypoglycaemic episodes

    Time frame: during 26 weeks of insulin therapy

Secondary outcomes

  1. Frequency and type of hypoglycaemic episodes

    Time frame: during 26 weeks of insulin therapy

  2. Frequency and type of adverse events

    Time frame: during 26 weeks of insulin therapy

  3. Frequency and type of adverse drug reactions

    Time frame: during 26 weeks of insulin therapy

  4. Change in HbA1c from baseline

    Time frame: during 26 weeks of insulin therapy

  5. Change in PPG from baseline

    Time frame: during 26 weeks of insulin therapy

  6. Change in FPG from baseline

    Time frame: during 26 weeks of insulin therapy

  7. Subjects' insulin treatment satisfaction

    Time frame: during 26 weeks of insulin therapy

  8. Physicians' satisfaction with insulin therapy

    Time frame: during 26 weeks of insulin therapy

  9. Weight change

    Time frame: at the end of the study

  10. Percentage of patients reaching the target of HbA1c less than 7.5%

    Time frame: at the end of the study

  11. Percentage of patients reaching the target of HbA1c less than 7%

    Time frame: at the end of the study

  12. Percentage of patients reaching the target of HbA1c less than 6.5%

    Time frame: at the end of the study

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2008
Registry last updated
Nov 7, 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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