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.
Approved by South East Multicentre Research Ethics Committee (MREC) on 03/05/2002 reference number: MREC 01/1/67
Double-blind, randomised, crossover study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Type 2 diabetes requiring insulin
Crossover trial comparing the glucose control of using NovoMix® 30 to Mixtard® 30.
Biphasic Insulin Aspart 30 (NovoMix® 30), Biphasic Human Insulin 30 (Mixtard® 30)
Primary outcome measure
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
3. Diabetes treatment satisfaction questionnaire
4. Adverse event recording
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
Department of Diabetes and Endocrinology
Novo Nordisk Ltd (UK)
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)
Results in http://www.ncbi.nlm.nih.gov/pubmed/17277042
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.