PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine

Criteria

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.