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| 32-week, multicentre, open, randomised, two-way cross-over, clinical trial comparing insulin glargine (HOE 901) in combination with insulin lispro and neutral protamine Hagedorn in combination with regular human insulin in subjects with type one diabetes mellitus on a meal-time and basal insulin regimen |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN83582782 |
| Date ISRCTN assigned | 17/04/2007 |
| Local reference number(s) | HOE 901/4006 |
| Public title | 32-week, multicentre, open, randomised, two-way cross-over, clinical trial comparing insulin glargine (HOE 901) in combination with insulin lispro and neutral protamine Hagedorn in combination with regular human insulin in subjects with type one diabetes mellitus on a meal-time and basal insulin regimen |
| Scientific title | |
| Acronym | The Home Study |
| Disease/condition/study domain | Type one diabetes mellitus |
| Study hypothesis | Insulin glargine plus insulin lispro improves blood glucose control in people with type one diabetes as assessed by HbA1c compared to Neutral Protamine Hagedorn (NPH) insulin plus unmodified human insulin. |
| Design/methodology | Open, randomised, two-way cross-over trial |
| Research ethics review | Approval received from local Multicentre Research Ethics Committee (MREC) in December 2000 (ref: 0/3/56). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Men and women, aged 18 to 65 years 2. Type one diabetes mellitus as shown by C-peptide deficient status (less than 0.10 nmol/L when plasma glucose is greater than 4.5 mmol/L) 3. More than one year on a daily multiple insulin injection regimen 4. Experience in Self Monitoring of Blood Glucose (SMBG), interpretation of SMBG results and insulin dose adjustments 5. HbA1c greater than 7.0% and less than 9.5% at visit one 6. Willingness to actively adjust the insulin doses in order to achieve the target blood glucose levels and to perform SMBG profiles using the Accutrend Sensor Complete on a regular basis as specified in the study protocol 7. Women of childbearing potential are to be using adequate contraceptive protection |
| Participants - exclusion criteria | 1. Treatment with blood-glucose-lowering drugs other than insulin in the last eight weeks before screening visit (visit one) 2. Use of an investigational drug other than insulin in the last six months before study entry, or use of an investigational insulin in the last four weeks before study entry 3. Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the three months before study entry or which may require surgical treatment within three months of study entry as evidenced by retino-screening within the last 12 months 4. History of repeated severe hypoglycaemia with unconsciousness within the last two years 5. Night shift workers 6. Pancreatectomised subjects 7. Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult 8. History of drug or alcohol abuse 9. Pregnant (as determined by pregnancy blood test at visit one) or breast-feeding women 10. Impaired hepatic function, as shown by but not limited to Serum Glutamic Pyruvic Transaminase (SGPT) (ALanine AminoTransferase [ALAT]) or Serum Glutamic-Oxaloacetic Transaminase (SGOT) (ASpartate AminoTransferase [ASAT]) above 2 x the upper limit of normal measured at visit one 11. Impaired renal function, as shown by but not limited to serum creatinine greater than 177 µmol/L (greater than 2.0 mg/dL) measured at visit one 12. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 13. Evidence of an uncooperative attitude 14. Inability to attend clinical visits 15. Known employee of sanofi-aventis |
| Patient information material | |
| Anticipated start date | 01/02/2001 |
| Anticipated end date | 01/09/2002 |
| Status of trial | Completed |
| Target number of participants | 71 |
| Interventions | Insulin glargine plus insulin lispro in one arm of study, NPH insulin plus unmodified human insulin in other arm. |
| Primary outcome measure(s) | HbA1c at end of treatment period. |
| Secondary outcome measure(s) | 1. Insulin doses 2. Pre-breakfast SMBG concentration 3. 24-hour eight-point SMBG levels 4. 24-hour in-patient plasma glucose levels 5. Monthly rate of hypoglycaemia |
| Publications | Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16492212 |
| Sources of funding | Sanofi-aventis (UK) |
| Sponsor name | Sanofi-aventis (UK) |
| Sponsor details | 1 Onslow Street Guildford, Surrey United Kingdom GU1 4YS |
| Sponsor telephone | +44 (0)1483 505515 |
| Sponsor fax | +44 (0)1483 535432 |
| Sponsor email | simon.shutler@sanofi-aventis.com |
| Sponsor website | http://www.sanofi-aventis.co.uk |
| Contact name | Prof Philip Home |
| Contact details | School of Clinical Medical Sciences - Diabetes Newcastle University Framlington Place Newcastle upon Tyne United Kingdom NE2 4HH |
| Contact telephone | +44 (0)191 222 8643/7019 |
| Contact fax | +44 (0)191 222 0723 |
| Contact email | philip.home@ncl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN83582782 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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