Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134107
• Other study ID #: 12175
• Secondary ID: F3Z-MC-IOPW
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2010
• Last updated: April 4, 2013
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardHungary: National Institute of PharmacyHungary: Research Ethics Medical CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months

• Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months

• Mean total daily insulin dose for 3 days prior to screening less than or equal to 46 units/day if using a 300-Unit reservoir, less than or equal to 30 units/day if using a 200 unit reservoir, or less than or equal to 26 units/day if using a 180 unit reservoir

• Baseline body mass index (BMI) less than or equal to 35.0 kilograms per meter squared (kg/m2)

• Baseline glycated hemoglobin A1c (HbA1c) 5% to 9%

Exclusion Criteria:

• Impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL))

• Legal blindness

• Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation

• Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose less than 45 mg/dL [2.5 millimoles per liter (mmol/L)]) in the 12 months prior to screening.

• Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.

• Have had a pump-related infusion site abscess in the 12 months prior to screening.

• Have had multiple, clinically significant occlusions as judged by the investigator.

• Have had any infection with Staphylococcus aureus in the past 5 years

• Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.

• Participants with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.

• Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.

• Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.

• Have an irregular sleep/wake cycle in the investigator's opinion.

• Have a known hypersensitivity or allergy to any of the study insulins or their excipients

• Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.

• Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.

• Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin Lispro 6 Day (6D)
Administered by infusion pump for 12 week treatment period
• Insulin Aspart 6 Day (6D)
Administered by infusion pump for 12 week treatment period

Locations

Country	Name	City	State
France	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Caen
France	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Corbeil-Essonnes
France	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	La Rochelle
France	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Marseille
France	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Montpellier
France	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Narbonne
Germany	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ludwigshafen
Germany	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mainz
Germany	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Münster
Germany	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Neuwied
Germany	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Potsdam
Hungary	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bekescsaba
Hungary	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Budapest
Hungary	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nyiregyhaza
Hungary	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Zalaegerszeg

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

France,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)		Baseline, endpoint for each 12-week treatment period	No
Other	Percentage of Participants Having a Hyperglycemic Episode	A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) and =3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating	Days 1-6 for each reservoir cycle throughout each 12-week treatment period	Yes
Other	Hyperglycemic Episode Rate Per 30 Days	Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [mmol/L]) and =3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.	Days 1-6 for each reservoir cycle throughout each 12-week treatment period	Yes
Other	Percentage of Participants With Pump Complications	Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.	Days 1-6 for each reservoir cycle throughout each 12-week treatment period	Yes
Other	Pump Complications Rate Per 30 Days	Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.	Days 1-6 for each reservoir cycle throughout each 12-week treatment period	Yes
Other	Percentage of Participants Having a Hypoglycemic Episode	A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).; All Reported Hypoglycemic Episodes are defined as an event which is associated with; reported signs and symptoms of hypoglycemia, and/or; a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)	All days for each reservoir cycle throughout each 12-week treatment period	Yes
Other	Hypoglycemic Episode Rate Per 30 Days	All Reported Hypoglycemic Episodes are defined as an event which is associated with; reported signs and symptoms of hypoglycemia, and/or; a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)	All days for each reservoir cycle throughout each 12-week treatment period	Yes
Other	Change From Baseline to 12 Week Endpoint for Each Treatment in Weight		Baseline, endpoint for each 12-week treatment period	No
Other	Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure		Baseline, endpoint for each 12-week treatment period	Yes
Primary	Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use		Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)	No
Secondary	Mean SMBG	Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D.	Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period	No
Secondary	Mean Daily Insulin Dose (Total, Basal, and Bolus)		Days 1-6 for each reservoir cycle throughout each 12-week treatment period	No
Secondary	Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values		Baseline, endpoint for each 12-week treatment period	No
Secondary	Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%		Endpoint for each 12-week treatment period	No