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Completed

NCT Number: NCT00184561

Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes

This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Beijing, Beijing Municipality, China

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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
  • HbA1C = 7.5%
  • Insulin naïve
  • Current treatment by Oral Anti-diabetic Drugs

Exclusion criteria

  • Severe medical conditions

Treatment and study plan

biphasic insulin aspart

Drug

Primary outcomes

  1. Change in HbA1c

    Time frame: After 24 weeks of treatment

Secondary outcomes

  1. Adverse events

  2. Weight change

  3. Fasting blood glucose

  4. Hypoglycaemic episodes

  5. 2-hour postprandial blood glucose

  6. after 24 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Change in HbA1c With Biphasic Insulin Aspart 70/30 in Two Different Treatment Regiments in Subjects With Type 2 Diabetes Inadequately Controlled With Oral Anti-diabetic Drug Therapy.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
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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