Type one diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Insulin glargine plus insulin lispro in one arm of study, NPH insulin plus unmodified human insulin in other arm.
Sponsors
Sanofi-aventis (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c at end of treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed