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OpenTrials
Completed

NCT Number: NCT00604396

Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

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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, Arlon, Belgium

Loading trial locations.

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 since diagnosis
  • Insulin naive subjects
  • OAD treatment for at least 4 months alone or combined with no more than two OADs
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-10.0%
  • Able and willing to use twice a day injections for the entire trial period

Exclusion criteria

  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 6 months
  • Acute insulin treatment for longer than 7 days in a row within the last 6 months
  • Secondary diabetes
  • Known maturity onset of diabetes of young (MODY)
  • Known or suspected allergy to trial product or related products

Treatment and study plan

insulin detemir

Drug

insulin NPH

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. Fasting plasma glucose

  2. Within-subject variation

  3. Incidence of total hypoglycaemic episodes

  4. Body weight

  5. Incidence of adverse events

  6. Insulin antibodies

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 30, 2008
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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