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

This study has been completed.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: February 6, 2008
Last updated: May 24, 2012
Last verified: May 2012
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 Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: biphasic human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: July 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: biphasic insulin aspart
    Other Name: BIASP
    Drug: biphasic human insulin

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00617565

China, Beijing
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Plamen Kozlovski Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00617565     History of Changes
Other Study ID Numbers: BIASP-1536 
Study First Received: February 6, 2008
Last Updated: May 24, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Biphasic Insulins
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Globin Zinc
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2016