Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

February 22, 2017 updated by: Novo Nordisk A/S

Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70

This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-276
        • Novo Nordisk Investigational Site
      • Bytom, Poland, 41-902
        • Novo Nordisk Investigational Site
      • Kamieniec Zabkowicki, Poland, 57-230
        • Novo Nordisk Investigational Site
      • Katowice, Poland, 40-053
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-261
        • Novo Nordisk Investigational Site
      • Nysa, Poland, 48-300
        • Novo Nordisk Investigational Site
      • Otwock, Poland, 05-400
        • Novo Nordisk Investigational Site
      • Radom, Poland, 26-600
        • Novo Nordisk Investigational Site
      • Ruda Slaska, Poland, 41-700
        • Novo Nordisk Investigational Site
      • Sosnowiec, Poland, 41-200
        • Novo Nordisk Investigational Site
      • Warsaw, Poland, 01-877
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-306
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
  • HbA1c (glycosylated haemoglobin) equal to or below 12%
  • Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  • Previous participation in this trial
  • Receipt of any investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIAsp
Drug: biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals
Experimental: Insulin aspart
Drug: biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals
Drug: insulin aspart
Administrated subcutaneously (s.c., under the skin) before lunch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Outcome Measure
Incidence of adverse events
7-point blood glucose profile
Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
Hypoglycaemic episodes (minor, major or nocturnal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2002

Primary Completion (Actual)

April 24, 2003

Study Completion (Actual)

April 24, 2003

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 2, 2012

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on biphasic insulin aspart 30

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe