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Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00605111
First received: January 18, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  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
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: Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 11 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects achieving treatment target of HbA1c below 7% [ Time Frame: at 11 and 24 weeks ] [ Designated as safety issue: No ]
  • 8-point plasma glucose profiles [ Time Frame: performed at 11 and 24 weeks ] [ Designated as safety issue: No ]
  • FPG [ Time Frame: at 11 weeks and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 193
Study Start Date: December 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
  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
Kota Bharu, Kelantan, Malaysia, 16150
Philippines
Quezon City, 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

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00605111     History of Changes
Other Study ID Numbers: BIASP-3021
Study First Received: January 18, 2008
Last Updated: June 5, 2012
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013