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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184561
First received: August 29, 2005
Last updated: June 15, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]
  • Weight change [ Designated as safety issue: No ]
  • Fasting blood glucose [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Designated as safety issue: No ]
  • 2-hour postprandial blood glucose [ Designated as safety issue: No ]
  • after 24 weeks of treatment. [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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, China
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Qian Hongyu Novo Nordisk (China) Pharmaceuticals Co., Ltd.
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, 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: June 15, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014