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Completed

NCT Number: NCT00865397

Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment

This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.

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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, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
  • Patient willing to sign informed consent
  • Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

Exclusion criteria

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
  • Subjects with hypersensitivity to Levemir® or to any of the ingredients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.

Treatment and study plan

insulin detemir

Drug

Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.

Other names: Levemir®, NN304

Primary outcomes

  1. Change in HbA1c

    Time frame: after 24 weeks

Secondary outcomes

  1. Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5%

    Time frame: after 12 weeks and 24 weeks

  2. Change in FPG (Fasting Plasma Glucose)

    Time frame: after 12 weeks and 24 weeks

  3. Change in body weight

    Time frame: after 12 weeks and 24 weeks

  4. Change in waist and hip circumference

    Time frame: after 12 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary

Acronym: HA-BOT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2009
Registry last updated
Nov 23, 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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