We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00617565
First Posted: February 18, 2008
Last Update Posted: February 24, 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 of biphasic insulin aspart 30 on postprandial glycaemic control.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Drug: biphasic human insulin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 2-hr postprandial plasma glucose (PPPG) excursion [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures:
  • HbA1c
  • Fasting plasma glucose

Enrollment: 219
Actual Study Start Date: July 8, 2003
Study Completion Date: November 26, 2003
Primary Completion Date: November 26, 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: biphasic insulin aspart
    Other Name: BIASP
    Drug: biphasic human insulin
  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 to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or 2 diabetes for at least 3 months
  • Stabilised on current treatment with premixed human insulin for at least 4 weeks
  • Body mass index (BMI) between 18-40 kg/m2
  • HbA1c below 13.0%
  • Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

  • The receipt of any investigational drug within the last three months prior to this trial
  • Has a history of drug abuse or alcohol dependence within the last 5 years
  • Active proliferative retinopathy requiring laser or surgical intervention within the last year
  • Recurrent major hypoglycaemia as judged by the Investigator
  • Known or suspected allergy to trial product or related product
  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): NCT00617565


Locations
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100034
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100730
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100853
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200032
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200433
China
Novo Nordisk Investigational Site
Beijing, China, 100029
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00617565     History of Changes
Other Study ID Numbers: BIASP-1536
First Submitted: February 6, 2008
First Posted: February 18, 2008
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune 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