Brief 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. 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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

289

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Jan 2008

Geographic Reach

11 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

January 1, 2008

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed

13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 30, 2010

Completed

Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

1.4 years

First QC Date

January 23, 2008

Results QC Date

June 30, 2010

Last Update Submit

August 26, 2010

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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.
over 13 weeks of each treatment period

Secondary Outcomes (16)

Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
over 13 weeks of each treatment period
Percentage of Patients With at Least One Unexplained Hyperglycemia
over 13 weeks of each treatment period
Monthly Rate of Unexplained Hyperglycemia
over 13 weeks of each treatment period
Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
over 13 weeks of each treatment period
Monthly Rate of Confirmed Infusion Set Occlusion
over 13 weeks of each treatment period
+11 more secondary outcomes

Study Arms (3)

sequence 1

EXPERIMENTAL

sequence 1: insulin glulisine / insulin aspart / insulin lispro.

Drug: Insulin glulisineDrug: Insulin lisproDrug: Insulin aspart

Sequence 2

EXPERIMENTAL

Sequence 2: insulin aspart / insulin lispro / insulin glulisine

Drug: Insulin glulisineDrug: Insulin lisproDrug: Insulin aspart

Sequence 3

EXPERIMENTAL

Sequence 3: insulin lispro / insulin glulisine / insulin aspart

Drug: Insulin glulisineDrug: Insulin lisproDrug: Insulin aspart

Interventions

Insulin glulisineDRUG

100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Sequence 2Sequence 3sequence 1

Insulin lisproDRUG

100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Sequence 2Sequence 3sequence 1

Insulin aspartDRUG

100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Sequence 2Sequence 3sequence 1

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
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
+4 more criteria

Contact the study team to confirm eligibility.