PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540709
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : February 17, 2012
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Insulin Glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2002
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Primary efficacy data was HbA1c. [ Time Frame: At week 24 (the last day of the treatment period). ]

Secondary Outcome Measures :
  1. Secondary efficacy data included HbA1c. [ Time Frame: At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00540709

Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00540709     History of Changes
Other Study ID Numbers: HOE901 4036
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs