Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

January 4, 2017 updated by: Novo Nordisk A/S

A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

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

  • United Kingdom
      • Newcastle, United Kingdom
        • 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:

  • Subjects with Type 2 diabetes
  • Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
  • HbA1c maximum 10.0%
  • BMI (Body Mass Index) maximum 35.0 kg/m2
  • Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria:

  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose minimum 2.0 U/(kg·day)
  • A history of drug abuse or alcohol dependence within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Severe, uncontrolled hypertension

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment period 1
Drug: biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
Drug: biphasic insulin aspart 70
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
Drug: biphasic human insulin 30
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
Active Comparator: Treatment period 2
Drug: biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
Drug: biphasic insulin aspart 70
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
Drug: biphasic human insulin 30
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Glucose average in 24-hour blood glucose profiles

Secondary Outcome Measures

Outcome Measure
Adverse events
Pre-meal glucose level
Post-meal excursion of glucose (0-4 hours)
Cmax, maximum concentration of total insulin
tmax, time of maximum concentration of total insulin
The area under the 24-hour total insulin concentration time curve

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

May 1, 2002

Primary Completion (Actual)

November 1, 2002

Study Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimate)

February 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1319

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.

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