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Completed

NCT Number: NCT00318786

Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 2 diabetes
  • Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
  • HbA1c at least 7.5% and below 10.0%

Exclusion criteria

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired hepatic and/or renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Known hypoglycemia unawareness or recurrent major hypoglycemia

Treatment and study plan

biphasic insulin aspart

Drug

Primary outcomes

  1. Hemoglobin A1C (HbA1C)

    Time frame: After 16 weeks of treatment

Secondary outcomes

  1. HbA1C, after 28 weeks of treatment; Plasma glucose levels

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2006
Registry last updated
Jan 6, 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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