Text Size

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
  Purpose

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 Intervention Phase
Diabetes Mellitus
 Drug: Insulin Glargine
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

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

Enrollment: 58
Study Start Date: November 2002
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540709

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00540709     History of Changes
Other Study ID Numbers: HOE901 4036
Study First Received: October 5, 2007
Last Updated: February 15, 2012
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013