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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00184561
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : July 2005
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: After 24 weeks of treatment ]

Secondary Outcome Measures :
  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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1C = 7.5%
  • Insulin naïve
  • Current treatment by Oral Anti-diabetic Drugs

Exclusion Criteria:

  • Severe medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184561


Locations
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100029
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100730
China, Guangdong
Novo Nordisk Investigational Site
Guangzhou, Guangdong, China, 510120
China, Hubei
Novo Nordisk Investigational Site
Wuhan, Hubei, China, 430022
China, Jiangsu
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210008
China, Shaanxi
Novo Nordisk Investigational Site
Xi'an, Shaanxi, China, 710032
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200003
China, Tianjin
Novo Nordisk Investigational Site
Tianjin, Tianjin, China, 300070
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184561     History of Changes
Other Study ID Numbers: BIASP-1707
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs