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 |
| Secondary identifying numbers | BIAsp-1466 |
- 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
Scientific
Department of Diabetes and Endocrinology
Leicester Infirmary Close
Leicester
LE1 5WW
United Kingdom
Study information
| Study design | Double-blind, randomised, crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 2. HbA1c 3. Diabetes treatment satisfaction questionnaire 4. Adverse event recording |
| Overall study start date | 05/06/2002 |
| Completion date | 07/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Diabetes and Endocrinology
Leicester
LE1 5WW
United Kingdom
LE1 5WW
United Kingdom
Sponsor information
Novo Nordisk Ltd (UK)
Industry
Industry
Broadfield Park
Brighton Road
Crawley
RH11 9RT
United Kingdom
| Phone | +44 (0)1293 613555 |
|---|---|
| gcom@novonordisk.com | |
| Website | http://www.novonordisk.co.uk |
"ROR" |
https://ror.org/0415cr103 |
Funders
Funder type
Industry
Novo Nordisk Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
