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 regime

Not Applicable

Completed

• Conditions: Type one diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN83582782
• Lead Sponsor: Sanofi-aventis (UK)

Brief Summary

2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16492212 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18339977

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2002-09-01
• Study Start: 2007-04-17
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 71

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified