PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540709
• Other study ID #: HOE901 4036
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2007
• Last updated: February 15, 2012
• Start date: November 2002
• Est. completion date: September 2003

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin Glargine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy data was HbA1c.		At week 24 (the last day of the treatment period).
Secondary	Secondary efficacy data included HbA1c.		At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements.