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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184561
First received: August 29, 2005
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • Adverse events
  • Weight change
  • Fasting blood glucose
  • Hypoglycaemic episodes
  • 2-hour postprandial blood glucose
  • after 24 weeks of treatment.

Enrollment: 321
Study Start Date: July 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184561     History of Changes
Other Study ID Numbers: BIASP-1707 
Study First Received: August 29, 2005
Last Updated: January 5, 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
Biphasic Insulins
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 20, 2017