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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014