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Completed

NCT Number: NCT00383877

Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).

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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

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • HbA1C greater than 7.5% and less than or equal to 11.0%
  • Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

Exclusion criteria

  • Previous acute treatment with insulin for more than 7 days.
  • Treatment with OAD(s) which does not adhere to the approval labeling.
  • Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.

Treatment and study plan

insulin detemir

Drug

insulin NPH

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 20 weeks of treatment

Secondary outcomes

  1. FBG

    Time frame: after 20 weeks of treatment

  2. Safety profile

    Time frame: during 20 weeks treatment

  3. Proportion of subjects achieving HbA1c less than or equal to 7.0%

    Time frame: after 20 weeks of treatment

  4. Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial

    Time frame: before breakfast during the trial at the end of the trial

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 4, 2006
Registry last updated
Jan 2, 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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