Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

January 3, 2017 updated by: Novo Nordisk A/S

A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 3

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

  • Denmark
      • Århus C, Denmark, 8000
        • 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
  • Duration of diabetes for longer than 12 months
  • Body mass index (BMI) below 35.0 kg/m^2
  • HbA1c below 11.0 %
  • Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion Criteria:

  • Current treatment with agents affecting glucose metabolism
  • History of drug or alcohol dependence
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Proliferative retinopathy
  • Recurrent severe hypoglycaemia or advanced neuropathy

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIAsp 70
Drug: biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
Drug: biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
Experimental: BIAsp 70 + BIAsp 50
Drug: biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
Drug: biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
Drug: biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) at dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting serum glucose

Secondary Outcome Measures

Outcome Measure
Incidence of adverse events
Incidence of hypoglycaemic episodes
24-hour serum glucose profiles
24-hour insulin profiles

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.

General Publications

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

March 1, 1999

Primary Completion (Actual)

June 1, 1999

Study Completion (Actual)

June 1, 1999

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1074

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 70

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe