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OpenTrials
Completed

NCT Number: NCT00274274

Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects 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 4

Primary location

Düsseldorf, Germany

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 6 months
  • Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
  • Body Mass Index (BMI) less than or equal to 40 kg/m2
  • HbA1c 7.0-11.0%

Exclusion criteria

  • Treatment with short acting insulin(s) for longer than 10 days
  • Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
  • Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months

Treatment and study plan

insulin detemir

Drug

insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 52 weeks

Secondary outcomes

  1. Blood glucose profiles

  2. Percentage of patients with HbA1c less than 7.0% after 52 weeks

  3. Quality of Life

  4. Frequency of BG measurements

  5. Safety parameters

  6. Duration of education

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 10, 2006
Registry last updated
Nov 21, 2014

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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