A double-blind, randomised, crossover study to investigate the difference in frequency of episodes of hypoglycaemia during treatment with Biphasic Insulin Aspart 30 (NovoMix®30) compared to Biphasic Human Insulin 30 (Mixtard® 30) in patients with well-controlled, type 2 diabetes

ISRCTN	ISRCTN34091554
DOI	https://doi.org/10.1186/ISRCTN34091554
Protocol serial number	BIAsp-1466
Sponsor	Novo Nordisk Ltd (UK)
Funder	Novo Nordisk Ltd (UK)

Submission date: 07/06/2006
Registration date: 19/06/2006
Last edited: 19/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul McNally
Scientific

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

Study information

Primary study design	Interventional
Study design	Double-blind, randomised, crossover study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	REACH
Study objectives	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(s)	Approved by South East Multicentre Research Ethics Committee (MREC) on 03/05/2002 reference number: MREC 01/1/67
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Biphasic Insulin Aspart 30 (NovoMix® 30), Biphasic Human Insulin 30 (Mixtard® 30)
Primary outcome measure(s)	Frequency of hypoglycaemic episodes measured by CGMS for three days.
Key secondary outcome measure(s)	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
Completion date	07/11/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	160
Key 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
Key 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
Date of first enrolment	05/06/2002
Date of final enrolment	07/11/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Diabetes and Endocrinology

Leicester
LE1 5WW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/05/2007		Yes	No