PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro

NCT ID: NCT00540709

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2003-09-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insulin Glargine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

References

Bolli GB, Kerr D, Thomas R, Torlone E, Sola-Gazagnes A, Vitacolonna E, Selam JL, Home PD. Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study. Diabetes Care. 2009 Jul;32(7):1170-6. doi: 10.2337/dc08-1874. Epub 2009 Apr 23.

Reference Type: DERIVED

PMID: 19389820 (View on PubMed)

Other Identifiers

HOE901 4036

Identifier Type: -

Identifier Source: org_study_id