Diabetes Mellitus, Type 1Phase 4PUMPNCT00607087
Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
A Phase 4 study testing Insulin glulisine, Insulin lispro and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Sanofi at 12 sites in 12 countries.
Trial summary
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin glulisine, Insulin lispro and Insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Jan 2008to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetic subjects
- Treated with insulin for at least 2 years and by CSII for at least 6 months
- Using the same insulin (insulin glulisine, insulin aspart or insulin lispro) in CSII for at least 3 months with the same external pump compatible with the 3 short acting insulin analogues used in the study
- Using the same type of infusion set (catheter and cannula) for at least 3 months
- Performing at least 3 blood glucose controls per day
- HbA1c < 8.5%
- Body mass index (BMI) < 35 kg/m²
- Ability and willingness to perform blood glucose and ketone monitoring using the Sponsor-provided combined glucose and ketone meter and patient diary at home
Who cannot join
- Diabetes other than Type 1
- Total daily dose of insulin greater than 90 U/day
- Using an insulin pump requiring pre-filled cartridges
- History of infection at infusion site requiring a drainage in the last 3 months
- History of severe episodes of ketosis requiring hospitalization in the last 6 months
- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study. An ophthalmoscopic examination should have been performed in the 2 years prior to study entry
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- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) or breastfeeding
- Treatment with systemic corticosteroids or medication known to influence insulin sensitivity in the 3 months prior to visit 1
- Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1
- Likelihood of requiring treatments during the study which are not permitted
- Treatment with an investigational product in the 30 days prior to visit 1
- History of sensitivity to the study drugs or to drugs with a similar chemical structure
- Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the Investigator feels would compromise the patient safety or limit his/her successful participation in the study
- Night shift workers
- Impaired renal function as shown by serum creatinine ≥1.5 mg/dL (133 μmol/L) or ≥1.4 mg/dL (124 μmol/L) in men and women, respectively
- Impaired hepatic function as shown by Alanine aminotransferase (ALT) and/or Aspart aminotransferase (AST) greater than three times the upper limit of normal range)
- Alcohol or drug abuse in the last year
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion.
Main Secondary objectives:
To compare insulin glulisine, insulin aspart and insulin lispro on:
- Unexplained hyperglycemia
- Infusion set occlusion
- Hypoglycemic episodes,7-point blood glucose profiles
- Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
- Time to change the infusion set
- HbA1c (Glycosylated hemoglobin)
- Overall safety: incidence of adverse events
Read the detailed description
The maximal duration of the study participation for patients was 41 weeks and one day, split in:
- a 2-week screening period,
- a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart)
- and a follow-up period of 24 hours.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin glulisine, Insulin lispro, Insulin aspart
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glulisineDrug
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin lisproDrug
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin aspartDrug
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
| Study group | Role | What they receive |
|---|---|---|
| sequence 1 | Experimental | sequence 1: insulin glulisine / insulin aspart / insulin lispro. Receives: Drug: Insulin glulisine; Drug: Insulin lispro; Drug: Insulin aspart |
| Sequence 2 | Experimental | Sequence 2: insulin aspart / insulin lispro / insulin glulisine Receives: Drug: Insulin glulisine; Drug: Insulin lispro; Drug: Insulin aspart |
| Sequence 3 | Experimental | Sequence 3: insulin lispro / insulin glulisine / insulin aspart Receives: Drug: Insulin glulisine; Drug: Insulin lispro; Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Pump infusion set occlusion defined by at least one of the following items:
- pump occlusion alarm,
- patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
Measured: over 13 weeks of each treatment period
Secondary outcomes (16)
Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Pump infusion set occlusion defined by at least one of the following items:
- pump occlusion alarm,
- patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
Measured: over 13 weeks of each treatment period
Percentage of Patients With at Least One Unexplained Hyperglycemia
Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Measured: over 13 weeks of each treatment period
Monthly Rate of Unexplained Hyperglycemia
Measured: over 13 weeks of each treatment period
Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
Pump infusion set occlusion defined by at least one of the following items:
- pump occlusion alarm,
- patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
Measured: over 13 weeks of each treatment period
Monthly Rate of Confirmed Infusion Set Occlusion
Measured: over 13 weeks of each treatment period
Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).
Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l
Measured: over 13 weeks of each treatment period
Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).
Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l
Measured: over 13 weeks of each treatment period
Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year
Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration.
Measured: over 13 weeks of each treatment period
Rate of Severe Symptomatic Hypoglycemia Per Patient-year
Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:
- the event was associated with a measured blood glucose level below 36 mg/dL
- or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
Measured: over 13 weeks of each treatment period
Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year
Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning.
Measured: over 13 weeks of each treatment period
Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site
Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.
Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.
Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.
Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection.
Measured: over 13 weeks of each treatment period
Time Interval Between Infusion Set Changes: All Changes
Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).
"All changes" include all the changes whatever the reason such as routine or requested by occurrence of events.
Measured: over 13 weeks of each treatment period
Time Interval Between Infusion Set Changes in Routine
Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).
Changes in routine correspond to interval between changes according to patient use.
Measured: over 13 weeks of each treatment period
Glycosylated Hemoglobin: HbA1c
Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%
Measured: over 13 weeks of each treatment period
Total Daily Basal Insulin Infusion
dose of the basal insulin regimen administered throughout the 24-hour period
Measured: over 13 weeks of each treatment period
Total Daily Bolus Insulin Dose
dose of every increment administered for example before meals
Measured: over 13 weeks of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Affairs, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607087
- Sponsor's protocol ID
- APIDR_C_02083
- Other IDs
- 2007-003579-38
- Acronym
- PUMP
- Status last verified
- Aug 2010
- First submitted
- 23 Jan 2008
- Last updated
- 31 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
van Bon AC, Bode BW, Sert-Langeron C, DeVries JH, Charpentier G. Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther. 2011 Jun;13(6):607-14. doi: 10.1089/dia.2010.0224. Epub 2011 Apr 2.
PubMed 21457066
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00607087
- Acronym / sponsor ID
- PUMP / APIDR_C_02083
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 30 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion.
Main Secondary objectives:
To compare insulin glulisine, insulin aspart and insulin lispro on:
- Unexplained hyperglycemia
- Infusion set occlusion
- Hypoglycemic episodes,7-point blood glucose profiles
- Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
- Time to change the infusion set
- HbA1c (Glycosylated hemoglobin)
- Overall safety: incidence of adverse events
Detailed description
The maximal duration of the study participation for patients was 41 weeks and one day, split in:
- a 2-week screening period,
- a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart)
- and a follow-up period of 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sequence 1 | Experimental | Drug: Insulin glulisine, Drug: Insulin lispro, Drug: Insulin aspartsequence 1: insulin glulisine / insulin aspart / insulin lispro. |
| Sequence 2 | Experimental | Drug: Insulin glulisine, Drug: Insulin lispro, Drug: Insulin aspartSequence 2: insulin aspart / insulin lispro / insulin glulisine |
| Sequence 3 | Experimental | Drug: Insulin glulisine, Drug: Insulin lispro, Drug: Insulin aspartSequence 3: insulin lispro / insulin glulisine / insulin aspart |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 diabetic subjects
- Treated with insulin for at least 2 years and by CSII for at least 6 months
- Using the same insulin (insulin glulisine, insulin aspart or insulin lispro) in CSII for at least 3 months with the same external pump compatible with the 3 short acting insulin analogues used in the study
- Using the same type of infusion set (catheter and cannula) for at least 3 months
- Performing at least 3 blood glucose controls per day
Key exclusion criteria (19 listed)
- Diabetes other than Type 1
- Total daily dose of insulin greater than 90 U/day
- Using an insulin pump requiring pre-filled cartridges
- History of infection at infusion site requiring a drainage in the last 3 months
- History of severe episodes of ketosis requiring hospitalization in the last 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 glulisine100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump | Drug | Sequence 2, Sequence 3, sequence 1 |
| Insulin lispro100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump | Drug | Sequence 2, Sequence 3, sequence 1 |
| Insulin aspart100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump | Drug | Sequence 2, Sequence 3, sequence 1 |
Primary outcome
Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Time frame: over 13 weeks of each treatment period
Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason. Pump infusion set occlusion defined by at least one of the following items: * pump occlusion alarm, * patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
16 secondary outcomes
Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Time frame: over 13 weeks of each treatment period
Percentage of Patients With at Least One Unexplained Hyperglycemia
Time frame: over 13 weeks of each treatment period
Monthly Rate of Unexplained Hyperglycemia
Time frame: over 13 weeks of each treatment period
Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
Time frame: over 13 weeks of each treatment period
Monthly Rate of Confirmed Infusion Set Occlusion
Time frame: over 13 weeks of each treatment period
Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Time frame: over 13 weeks of each treatment period
Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Time frame: over 13 weeks of each treatment period
Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year
Time frame: over 13 weeks of each treatment period
Rate of Severe Symptomatic Hypoglycemia Per Patient-year
Time frame: over 13 weeks of each treatment period
Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year
Time frame: over 13 weeks of each treatment period
Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site
Time frame: over 13 weeks of each treatment period
Time Interval Between Infusion Set Changes: All Changes
Time frame: over 13 weeks of each treatment period
Time Interval Between Infusion Set Changes in Routine
Time frame: over 13 weeks of each treatment period
Glycosylated Hemoglobin: HbA1c
Time frame: over 13 weeks of each treatment period
Total Daily Basal Insulin Infusion
Time frame: over 13 weeks of each treatment period
Total Daily Bolus Insulin Dose
Time frame: over 13 weeks of each treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21457066van Bon AC, Bode BW, Sert-Langeron C, DeVries JH, Charpentier G. Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther. 2011 Jun;13(6):607-14. doi: 10.1089/dia.2010.0224. Epub 2011 Apr 2.
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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.
Medical Affairs study director
Sanofi
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin glulisine, Insulin lispro and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Sanofi at 12 sites in 12 countries.
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 8 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 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia, Austria, France, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 30 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion (time frame: over 13 weeks of each 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 NCT00607087, 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 31 Aug 2010.