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
| ISRCTN | ISRCTN83582782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83582782 |
| Secondary identifying numbers | HOE 901/4006 |
- Submission date
- 21/02/2007
- Registration date
- 17/04/2007
- Last edited
- 27/10/2022
- 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 Philip Home
Scientific
Scientific
School of Clinical Medical Sciences - Diabetes
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 222 8643/7019 |
|---|---|
| philip.home@ncl.ac.uk |
Study information
| Study design | Open, randomised, two-way cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | The Home Study |
| Study objectives | 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. |
| Ethics approval(s) | Approval received from local Multicentre Research Ethics Committee (MREC) in December 2000 (ref: 0/3/56). |
| Health condition(s) or problem(s) studied | Type one diabetes mellitus |
| Intervention | Insulin glargine plus insulin lispro in one arm of study, NPH insulin plus unmodified human insulin in other arm. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin glargine, insulin lispro, NPH insulin, unmodified human insulin |
| Primary outcome measure | HbA1c at end of treatment period. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2001 |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 71 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 01/09/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Clinical Medical Sciences - Diabetes
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Sanofi-aventis (UK)
Industry
Industry
1 Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
| Phone | +44 (0)1483 505515 |
|---|---|
| simon.shutler@sanofi-aventis.com | |
| Website | http://www.sanofi-aventis.co.uk |
"ROR" |
https://ror.org/05bf2vj98 |
Funders
Funder type
Industry
Sanofi-aventis (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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2006 | Yes | No | ||
| Results article | 01/06/2008 | Yes | No |
Editorial Notes
27/10/2022: Internal review.
