Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes (REACH)

January 5, 2017 updated by: Novo Nordisk A/S

A Double-blind, Randomised, Crossover Study to Investigate the Difference in Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 Compared to Biphasic Human Insulin 30 in Patients With Well-controlled Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

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

  • United Kingdom
      • Bolton, United Kingdom, BL1 4QS
        • Novo Nordisk Investigational Site
      • Cardiff, United Kingdom, CF14 4XW
        • Novo Nordisk Investigational Site
      • Derby, United Kingdom, DE7 1DY
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Exeter, United Kingdom, EX2 5AX
        • Novo Nordisk Investigational Site
      • Galway, United Kingdom, EIRE
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE1 5WW
        • Novo Nordisk Investigational Site
      • Liverpool, United Kingdom, L7 8XP
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE1 7EH
        • Novo Nordisk Investigational Site
      • London, United Kingdom, NW10 7NS
        • Novo Nordisk Investigational Site
      • Newcastle, United Kingdom, NE7 7DN
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Upton, United Kingdom, L49 5PE
        • Novo Nordisk Investigational Site
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • Novo Nordisk Investigational Site
      • York, United Kingdom, YO3 7HE
        • 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
  • Treated with insulin 1-3 injections daily for at least 6 months
  • Body Mass Index (BMI) below 40 kg/m^2
  • HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening

Exclusion Criteria:

  • Total insulin dosage more than 1.8 IU/kg
  • Impaired hepatic or renal function or significant cardiac problems

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment period 1
Drug: biphasic human insulin 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
Drug: biphasic insulin aspart 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
ACTIVE_COMPARATOR: Treatment period 2
Drug: biphasic human insulin 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
Drug: biphasic insulin aspart 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Frequency of hypoglycaemic episodes

Secondary Outcome Measures

Outcome Measure
Frequency of reported severe hypoglycaemic episodes
Overall frequency of nocturnal hypoglycaemia
HbA1c (glycosylated haemoglobin A1c)
Diabetes Treatment Satisfaction Questionaire

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

June 1, 2002

Primary Completion (ACTUAL)

November 1, 2003

Study Completion (ACTUAL)

November 1, 2003

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (ESTIMATE)

December 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1466

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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