Diabetes Mellitus
Conditions
Brief summary
Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by continuous subcutaneous insulin infusion in Type 1 diabetic patients.
Interventions
DRUGInsulin Glargine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of type 1 diabetes mellitus for at least one year. * Subjects with no previous experience with Continuous Subcutaneous Insulin Infusion (CSII) or insulin glargine, * capable of managing a basal-bolus regimen and meeting glycaemic targets in accordance with the protocol. * HbA1c \> than or = to 6.5 \< than or = to 9.0% at screening visit with evidence of lack of insulin secretion (e.g. fasting C-peptide concentration is \< 0.1 nmol/l with fasting blood glucose(FBG) \> 126 mg/dl).
Exclusion criteria
* Previous therapy using insulin glargine or continuous subcutaneous insulin infusion. * Lipodystrophy preventing adequate use of CSII. * Unwilling or unlikely to be able to use MiniMedr insulin pump with insulin lispro for CSII. * Unwilling or unlikely to be able to use an MDI regimen with insulin glargine and insulin lispro in accordance with the protocol (for instance, subjects who routinely use a twice-daily mixed insulin regimen should not be included). * History of more than two severe hypoglycaemic episodes in the past 6 months. * Acute infection which, in the opinion of the investigator, could lead to increased insulin resistance. * Acute or chronic metabolic acidosis. * Episode of DKA (diabetic ketoacidosis) within the last three months. * Active, uncontrolled, advanced diabetic retinopathy. * Impaired hepatic function, as shown by \> 2.5 times the upper limit of normal range for AST. * Impaired renal function, as shown by serum creatinine \> 1.5mg/dl. * History of gastroparesis. Congestive heart failure requiring ongoing pharmacological treatment. * Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months. * Treatment with a non-selective beta blocker. * Treatment with inhaled or systemic steroids. * History of hypersensitivity to insulin lispro or to any drug with a similar chemical structure to insulin glargine or insulin lispro or to any of the excipients of the insulin glargine and insulin lispro preparations used in the study. * Any malignancy within the last five years, except adequately treated basal cell carcinoma. * History within the last two years or current addiction to substances of abuse including ethanol. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy data was HbA1c. | At week 24 (the last day of the treatment period). |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy data included HbA1c. | At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements. |
Outcome results
None listed