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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00617565
First received: February 6, 2008
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617565

Locations
China, Beijing
Beijing, Beijing, China, 100730
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: 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013