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OpenTrials
Completed

NCT Number: NCT00283751

Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

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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 3

Primary location

Novo Nordisk Investigational Site, Ebreichsdorf, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 Diabetes for more than 12 months, and no previous insulin treatment
  • Oral Antidiabetic Drug treatment for at least 4 months
  • Body Mass Index (BMI) less than 40 kg/m2
  • HbA1c 7.5-10.0%

Exclusion criteria

  • Current or previous treatment with thiazolidinediones within the last 6 months
  • Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
  • Proliferative retinopathy or maculopathy
  • Known hypoglycaemia unawareness

Treatment and study plan

insulin detemir

Drug

insulin glargine

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 52 weeks

Secondary outcomes

  1. Insulin antibodies

  2. Incident of hypoglycaemic episodes and adverse events

  3. Plasma glucose profiles

  4. Change in body weight

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 30, 2006
Registry last updated
Jan 27, 2017

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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