Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Philip Home
+44 (0)191 222 8643/7019
philip.home@ncl.ac.uk


Study Location:

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English | Cymraeg
Be Part of Research - Trial Details - 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

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

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Type one diabetes mellitus


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Not provided at time of registration

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2001 01 Sep 2002

Publications

2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/164922122008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18339977

Interventional

Intervention Type : Drug
Intervention Description : Insulin glargine plus insulin lispro in one arm of study, NPH insulin plus unmodified human insulin in other arm.




You can take part if:



You may not be able to take part if:


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 entry3. 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 months4. History of repeated severe hypoglycaemia with unconsciousness within the last two years5. Night shift workers6. Pancreatectomised subjects7. Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult8. History of drug or alcohol abuse9. Pregnant (as determined by pregnancy blood test at visit one) or breast-feeding women10. 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 one11. 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 one12. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study13. Evidence of an uncooperative attitude14. Inability to attend clinical visits15. Known employee of sanofi-aventis


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

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

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.


The study is sponsored by Sanofi-aventis (UK) and funded by Sanofi-aventis (UK).





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Read full details for Trial ID: ISRCTN83582782
Last updated 27 October 2022

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