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Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00318786
First Posted: April 27, 2006
Last Update Posted: January 6, 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 Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Hemoglobin A1C (HbA1C) [ Time Frame: After 16 weeks of treatment ]

Secondary Outcome Measures:
  • HbA1C, after 28 weeks of treatment; Plasma glucose levels

Enrollment: 289
Study Start Date: April 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
  • HbA1c at least 7.5% and below 10.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired hepatic and/or renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Known hypoglycemia unawareness or recurrent major hypoglycemia
  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): NCT00318786


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
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: NCT00318786     History of Changes
Other Study ID Numbers: BIASP-1598
JapicCTI-060241 ( Registry Identifier: japic )
First Submitted: April 26, 2006
First Posted: April 27, 2006
Last Update Posted: January 6, 2017
Last Verified: January 2017

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