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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605111
First Posted: January 30, 2008
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605111


Locations
Australia, New South Wales
Novo Nordisk Investigational Site
Blacktown, New South Wales, Australia, 2148
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
Australia
Novo Nordisk Investigational Site
Fitzroy, Australia, 3065
Novo Nordisk Investigational Site
Garran, Australia, 2605
Novo Nordisk Investigational Site
Stones Corner, Australia, 4120
Hong Kong
Novo Nordisk Investigational Site
Hong Kong Island, Hong Kong
Novo Nordisk Investigational Site
Shatin, New Territories, Hong Kong
Malaysia
Novo Nordisk Investigational Site
Cheras, Malaysia, 56000
Novo Nordisk Investigational Site
Georgetown, Penang, Malaysia, 10450
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Philippines
Novo Nordisk Investigational Site
Cebu City, Philippines, 6000
Novo Nordisk Investigational Site
Quezon City, Philippines, 1100
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 159964
Taiwan
Novo Nordisk Investigational Site
Changhua, Taiwan, 500
Novo Nordisk Investigational Site
Kaoshiung, Taiwan, 807
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10300
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
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: NCT00605111     History of Changes
Other Study ID Numbers: BIASP-3021
First Submitted: January 18, 2008
First Posted: January 30, 2008
Last Update Posted: January 11, 2017
Last Verified: January 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 aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs