Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/06/2006
Date assigned
19/06/2006
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul McNally

ORCID ID

Contact details

Department of Diabetes and Endocrinology
Leicester Infirmary Close
Leicester
LE1 5WW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BIAsp-1466

Study information

Scientific title

Acronym

REACH

Study hypothesis

The trial is a double-blind, two-period cross-over, randomised, multicentre trial in insulin-treated subjects with type-2 diabetes comparing the efficacy and safety of NovoMix® 30 and Mixtard® 30.
Patients will first complete a screening and run-in period lasting eight weeks during which their current insulin dose will be adjusted to achieve pre-breakfast and pre-evening meal blood glucose levels of 5-7 mmol/l.
Patients who achieve an HbA1c of 6.5-8.5% at the end of the run-in period will be randomly allocated to treatment with either NovoMix® 30 or Mixtard® 30 for a 16-week treatment period.
At the end of this period patients will be crossed over to the alternative treatment. The second crossover period will also last for 16 weeks. Both insulin regimens will involve administration just before meals. Total duration of the trial will be 40 weeks. Patients will self-check blood-glucose levels daily. Insulin total dosage will be adjusted by a maximum of either plus or minus 10% using the following algorithm in order to improve blood-glucose profiles, based on the targets stated above. The primary assessment variable will be the number of glucose readings below 3.5 mmol/l as measured by continuous glucose monitoring system overview (CGMS) during two 72-hour periods mid-way through and at the end of each treatment period.

Ethics approval

Approved by South East Multicentre Research Ethics Committee (MREC) on 03/05/2002 reference number: MREC 01/1/67

Study design

Double-blind, randomised, crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetes requiring insulin

Intervention

Crossover trial comparing the glucose control of using NovoMix® 30 to Mixtard® 30.

Intervention type

Drug

Phase

Not Specified

Drug names

Biphasic Insulin Aspart 30 (NovoMix® 30), Biphasic Human Insulin 30 (Mixtard® 30)

Primary outcome measures

Frequency of hypoglycaemic episodes measured by CGMS for three days.

Secondary outcome measures

1. Frequency of reported severe hypoglycaemic episodes, minor hypoglycaemic events and nocturnal hypoglycaemia, during the last 12 weeks of each treatment period
2. HbA1c
3. Diabetes treatment satisfaction questionnaire
4. Adverse event recording

Overall trial start date

05/06/2002

Overall trial end date

07/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. 160 male or female, adult subjects, with type 2 diabetes and treated with 1 - 3 injections of insulin daily for at least six months
2. HbA1c less than 9.5% at screening and 6.5 - 8.5 at randomisation
3. Judged by the investigator to be eligible for a twice a day (BID) mixed-insulin treatment regimen

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Impaired hepatic, renal or cardiac function
2. Concomitant oral hypoglycaemic agents
3. History of frequent severe hypoglycaemic episodes requiring external assistance within the last six months

Recruitment start date

05/06/2002

Recruitment end date

07/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Diabetes and Endocrinology
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

Novo Nordisk Ltd (UK)

Sponsor details

Broadfield Park
Brighton Road
Crawley
RH11 9RT
United Kingdom
+44 (0)1293 613555
gcom@novonordisk.com

Sponsor type

Industry

Website

http://www.novonordisk.co.uk

Funders

Funder type

Industry

Funder name

Novo Nordisk Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17277042

Publication citations

  1. Results

    McNally PG, Dean JD, Morris AD, Wilkinson PD, Compion G, Heller SR, Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes., Diabetes Care, 2007, 30, 5, 1044-1048, doi: 10.2337/dc06-1328.

Additional files

Editorial Notes