Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/02/2007
Date assigned
17/04/2007
Last edited
03/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philip Home

ORCID ID

Contact details

School of Clinical Medical Sciences - Diabetes
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 8643/7019
philip.home@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HOE 901/4006

Study information

Scientific title

Acronym

The Home Study

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.

Ethics approval

Approval received from local Multicentre Research Ethics Committee (MREC) in December 2000 (ref: 0/3/56).

Study design

Open, randomised, two-way cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Insulin glargine, insulin lispro, NPH insulin, unmodified human insulin

Primary outcome measures

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 trial start date

01/02/2001

Overall trial end date

01/09/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

71

Participant 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

Recruitment start date

01/02/2001

Recruitment end date

01/09/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Clinical Medical Sciences - Diabetes
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Sanofi-aventis (UK)

Sponsor details

1 Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
+44 (0)1483 505515
simon.shutler@sanofi-aventis.com

Sponsor type

Industry

Website

http://www.sanofi-aventis.co.uk

Funders

Funder type

Industry

Funder name

Sanofi-aventis (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/16492212
2. http://www.ncbi.nlm.nih.gov/pubmed/18339977

Publication citations

  1. Ashwell SG, Amiel SA, Bilous RW, Dashora U, Heller SR, Hepburn DA, Shutler SD, Stephens JW, Home PD, Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes., Diabet. Med., 2006, 23, 3, 285-292, doi: 10.1111/j.1464-5491.2005.01781.x.

  2. Ashwell SG, Bradley C, Stephens JW, Witthaus E, Home PD, Treatment satisfaction and quality of life with insulin glargine plus insulin lispro compared with NPH insulin plus unmodified human insulin in individuals with type 1 diabetes., Diabetes Care, 2008, 31, 6, 1112-1117, doi: 10.2337/dc07-1183.

Additional files

Editorial Notes