- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00540709
PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro
February 15, 2012 updated by: Sanofi
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary efficacy data was HbA1c.
Time Frame: At week 24 (the last day of the treatment period).
|
At week 24 (the last day of the treatment period).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary efficacy data included HbA1c.
Time Frame: At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements.
|
At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
September 1, 2003
Study Completion (Actual)
September 1, 2003
Study Registration Dates
First Submitted
October 5, 2007
First Submitted That Met QC Criteria
October 5, 2007
First Posted (Estimate)
October 8, 2007
Study Record Updates
Last Update Posted (Estimate)
February 17, 2012
Last Update Submitted That Met QC Criteria
February 15, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOE901 4036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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