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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00184561
First received: August 29, 2005
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184561

Locations
China
Beijing, China
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Qian Hongyu Novo Nordisk (China) Pharmaceuticals Co., Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

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 aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013