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Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
This study has been completed.
Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00605111
  Purpose

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart
 Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Insulin aspart
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 11 weeks of treatment ]

Secondary Outcome Measures:
  • The proportion of subjects achieving treatment target of HbA1c below 7% [ Time Frame: at 11 and 24 weeks ]
  • 8-point plasma glucose profiles [ Time Frame: performed at 11 and 24 weeks ]
  • FPG [ Time Frame: at 11 weeks and 24 weeks ]

Estimated Enrollment: 234
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 24 months
  • BMI between 18 and 30 kg/m2
  • Insulin naive subjects
  • OAD treatment with max two OADs alone or combined with other therapy
  • HbA1c between 7-12%

Exclusion Criteria:

  • Type 1 diabetes
  • Receipt of any investigational drug within the last three months prior to this trial
  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 4 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605111

Locations
Australia, New South Wales
Broadmeadow, New South Wales, Australia, 2292
Hong Kong
Hong Kong Island, Hong Kong
Malaysia, Kelantan
Kubang Kerian, Kota Bharu, Kelantan, Malaysia, 16150
Philippines, Metro Manila
Quezon City, Metro Manila, Philippines, 1100
Singapore
Singapore, Singapore, 159964
Taiwan
Changhua, Taiwan, 500
Thailand
Bangkok, Thailand, 10330
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Plamen Kozlovski Novo Nordisk
  More Information

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

Responsible Party: Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers: BIASP-3021
Study First Received: January 18, 2008
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00605111  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Hong Kong: Department of Health;   Malaysia: Ministry of Health;   Philippines: Bureau of Food and Drugs;   Singapore: Health Sciences Authority;   Taiwan: Department of Health;   Thailand: Ministry of Public Health

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases
 Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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