Status:
COMPLETED
Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insu...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Belonging to a social security scheme or covered by such a scheme
- With type 1 diabetes (defined as a concentration of C-peptide \< 0.1 nmol//l and a fasting blood glucose of \>= 1.26 g/l), diagnosed not less than 5 years previously
- Treated for at least 6 months by intensive insulin treatment, following a basal-bolus system, using insulin glargine (Lantus®) as basal insulin. During the study, this insulin will administered in the evening
- Trained in the titration of prandial insulin (the dose of rapid insulin decided at each mealtime depending on the composition of the meal)
- With an HbA1c level of \<= 8.5% at the inclusion visit
- Capable of checking their blood glucose concentration using the material supplied by the sponsor: blood glucose meter and patient notebook
- Able to eat 3 regular daily meals on the days for recording the blood glucose cycle and similarly as much as possible on other days throughout the length of the study
- Able to continue their usual daily activities during the study
- Women of child-bearing potential should be using an effective method of contraception
- Fundal examination result less than a year old available
- Exclusion Criteria:
- Recent history of severe hypoglycaemia (at least 2 events in the 6 months prior to inclusion)
- An episode of acidocetosis in the 3 months prior to inclusion
- Proliferating retinopathy, defined as having required treatment by surgery or photocoagulation, in the 6 months prior to visit 1, or non-stabilised (rapidly developing) retinopathy which may require photocoagulation or surgery
- Pancreatectomy
- Altered hepatic function (AST or ALT \>= 2.5 x normal, in the initial measurements)
- Altered renal function (plasma creatinine \> 1.5 mg/dl)
- Acute infection
- Acute or chronic metabolic acidosis
- Gastroparesis
- History of cancer in the last 5 years
- Medically significant cardiovascular, hepatic, neurological or endocrine disease or any other significant disease making carrying out the protocol or interpreting the trial results difficult
- History of drug or alcohol abuse
- Subject likely to receive treatment during the trial which is not authorised in the protocol (see Section 6.2), in particular, treatment by corticosteroids whatever the route of administration or dose.
- Antidiabetic treatment by products other than those supplied within the framework of this study
- Treatment by another product undergoing development during the 3 months prior to inclusion in the trial
- Hypersensitivity to one of the study products (insulin glargine, insulin detemir, insulin glulisine) or to one of the excipients present in the insulin preparations, used in the study
- Working at night
- Pregnancy
- Breast-feeding
- Mental state making the subject incapable of understanding the objectives and possible consequences of the trial
- Subject unable to submit to the restrictions of the protocol (e.g. uncooperative, incapable of attending monitoring visits and probably incapable of finishing the trial)
- Subject deprived of his liberty because of an administrative or legal decision
- The investigator or any member of the team or close to the investigator directly implicated in the trial particularly assistant doctors, pharmacists, nurses, trial coordinator, etc.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00271284
Start Date
October 1 2005
End Date
September 1 2008
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Paris, France