Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin Lispro 6 Day (6D)

Insulin Aspart 6 Day (6D)

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Lispro 6 Day (6D)

Insulin Aspart 6 Day (6D)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Mean Daily Insulin Dose (Total, Basal, and Bolus)

Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values

Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%

Full Information

NCT ID

NCT01134107

First Posted

May 27, 2010

Last Updated

April 4, 2013

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01134107

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin Lispro 6 Day (6D)

Arm Type

Experimental

Arm Title

Insulin Aspart 6 Day (6D)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro 6 Day (6D)

Other Intervention Name(s)

Insulin Lispro Formulation, Humalog, LY275585

Intervention Description

Administered by infusion pump for 12 week treatment period

Intervention Type

Drug

Intervention Name(s)

Insulin Aspart 6 Day (6D)

Intervention Description

Administered by infusion pump for 12 week treatment period

Primary Outcome Measure Information:

Title

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

Time Frame

Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)

Secondary Outcome Measure Information:

Title

Mean SMBG

Description

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.

Time Frame

Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period

Title

Mean Daily Insulin Dose (Total, Basal, and Bolus)

Time Frame

Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Title

Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values

Time Frame

Baseline, endpoint for each 12-week treatment period

Title

Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%

Time Frame

Endpoint for each 12-week treatment period

Other Pre-specified Outcome Measures:

Title

Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)

Time Frame

Baseline, endpoint for each 12-week treatment period

Title

Percentage of Participants Having a Hyperglycemic Episode

Description

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

Time Frame

Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Title

Hyperglycemic Episode Rate Per 30 Days

Description

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.

Time Frame

Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Title

Percentage of Participants With Pump Complications

Description

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.

Time Frame

Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Title

Pump Complications Rate Per 30 Days

Description

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.

Time Frame

Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Title

Percentage of Participants Having a Hypoglycemic Episode

Description

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)

Time Frame

All days for each reservoir cycle throughout each 12-week treatment period

Title

Hypoglycemic Episode Rate Per 30 Days

Description

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)

Time Frame

All days for each reservoir cycle throughout each 12-week treatment period

Title

Change From Baseline to 12 Week Endpoint for Each Treatment in Weight

Time Frame

Baseline, endpoint for each 12-week treatment period

Title

Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure

Time Frame

Baseline, endpoint for each 12-week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

City

Corbeil-Essonnes

ZIP/Postal Code

91106

Country

France

Facility Name

City

La Rochelle

ZIP/Postal Code

17019

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Narbonne

ZIP/Postal Code

11108

Country

France

Facility Name

City

Ludwigshafen

ZIP/Postal Code

67059

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

55116

Country

Germany

Facility Name

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

City

Potsdam

ZIP/Postal Code

14469

Country

Germany

Facility Name

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs