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PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00540709
First received: October 5, 2007
Last updated: February 15, 2012
Last verified: February 2012
History of Changes

October 5, 2007
February 15, 2012
November 2002
September 2003   (final data collection date for primary outcome measure)
Primary efficacy data was HbA1c. [ Time Frame: At week 24 (the last day of the treatment period). ]
Same as current
Complete list of historical versions of study NCT00540709 on ClinicalTrials.gov Archive Site
Secondary efficacy data included HbA1c. [ Time Frame: At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements. ]
Same as current
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PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro
Not Provided

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: Insulin Glargine
Not Provided
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. Epub 2009 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
September 2003
September 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00540709
HOE901 4036
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP