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Completed

NCT Number: NCT00455858

Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.

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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

Interventional

Phase

Phase 4

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes (diagnosed more than 12 months ago)
  • HbA1c greater than 7.0 and less than 12.0% at screening
  • Currently on any OAD in more than 3 months ago
  • BMI (Body Mass Index) less than 35kg/m2

Exclusion criteria

  • Previous treatment with insulin in more than 7 days within the last 3 months
  • Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)

Treatment and study plan

insulin detemir

Drug

Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Other names: Levemir®

Primary outcomes

  1. Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20

    Time frame: week 0, week 20

    Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20

Secondary outcomes

  1. Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12

    Time frame: week 0, week 12

    Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline

  2. Change in Fasting Plasma Glucose (FPG)

    Time frame: week 0, week 12, week 20

    Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20

  3. Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%

    Time frame: week 12, week 20

    Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%

  4. Occurence of Hypoglycaemic Episodes

    Time frame: weeks 0-20

    Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 4, 2007
Registry last updated
Feb 1, 2024

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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