Diabetes MellitusPhase 4NCT00540709
PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro
A Phase 4 study testing Insulin Glargine in people with Diabetes Mellitus, run by Sanofi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin Glargine
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Sep 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin Glargine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy data was HbA1c.
Measured: At week 24 (the last day of the treatment period).
Secondary outcomes (1)
Secondary efficacy data included HbA1c.
Measured: At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startNov 2002
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540709
- Sponsor's protocol ID
- HOE901 4036
- Status last verified
- Feb 2012
- First submitted
- 5 Oct 2007
- Last updated
- 17 Feb 2012
- Results posted
- No
Publications
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. doi: 10.2337/dc08-1874. Epub 2009 Apr 23.
PubMed 19389820
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro
- ClinicalTrials.gov ID
- NCT00540709
- Acronym / sponsor ID
- HOE901 4036
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Glargine | Drug | – |
Primary outcome
Primary efficacy data was HbA1c.
Time frame: At week 24 (the last day of the treatment period).
1 secondary outcome
Secondary efficacy data included HbA1c.
Time frame: At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Derived from this study: PubMed 19389820Bolli 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. doi: 10.2337/dc08-1874. Epub 2009 Apr 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Glargine in people with Diabetes Mellitus, run by Sanofi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy data was HbA1c. (time frame: At week 24 (the last day of the treatment period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.