Diabetes Mellitus, Type 1Phase 3NCT01109316

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

A Phase 3 study testing Insulin lispro 2 day reservoir in-use, Insulin lispro 6 day reservoir in-use and Insulin aspart 6 day reservoir in-use in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of this study is to provide information on the use of insulin lispro in insulin pumps (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of pump reservoir in-use. Read more about this study

Who is it for?: Ages 13 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Insulin lispro 2 day reservoir in-use, Insulin lispro 6 day reservoir in-use and Insulin aspart 6 day reservoir in-use
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 11 sitesUnited States
Study dates: Apr 2010to Aug 2011
Phase: Phase 3
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 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months.
Treated with continuous subcutaneous insulin infusion therapy for the previous 6 months.
Mean total daily insulin dose for 3 days prior to screening equal to or less than 46 units/day using a 300-unit reservoir or less than or equal to 26 units/day using a 180 unit reservoir.
Baseline body mass index (BMI) less than or equal to 35.0 kg/m^2.
Baseline glycosylated hemoglobin (HbA1c) 5% to 9%.

Who cannot join

Impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per deciliter [mg/dL]).
Legal blindness.
Have had any episode of hypoglycemic coma, seizures, or disorientation in the 12 months prior to screening.
Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose (BG) less than 45 mg/dL) 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.

Show all 18Show fewer

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.
Patients 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 3 months prior to screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular and inhaled prescriptions), or have received such therapy within the 4 weeks immediately preceding screening.
Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night), in the investigator's opinion.
Have 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 an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have previously completed or withdrawn from this study after having signed the informed consent document (ICD).
Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

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.
Albany, New York, 12206
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.
Asheville, North Carolina, 28803
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.
Aurora, Colorado, 80045
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.
Austin, Texas, 78731
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.
Concord, California, 94520
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.
Hollywood, Florida, 33021
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.
Idaho Falls, Idaho, 83404
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.
Nashua, New Hampshire, 03063
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.
Syracuse, New York, 13210
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.
Topeka, Kansas, 66606
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.
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 1
Being tested: Insulin lispro 2 day reservoir in-use, Insulin lispro 6 day reservoir in-use, Insulin aspart 6 day reservoir in-use
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 lispro 2 day reservoir in-useDrug
Also called LY275585, Humalog
Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin lispro 6 day reservoir in-useDrug
Also called LY275585, Humalog
Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.
Insulin aspart 6 day reservoir in-useDrug
Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

Study groups in NCT01109316
Study group	Role	What they receive
Insulin Lispro 2 Day	Active comparator	Not described Receives: Drug: Insulin lispro 2 day reservoir in-use
Insulin Lispro 6 Day	Experimental	Not described Receives: Drug: Insulin lispro 6 day reservoir in-use
Insulin Aspart 6 Day	Active comparator	Not described Receives: Drug: Insulin aspart 6 day reservoir in-use

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use
Measured: 8 weeks of each treatment

Secondary outcomes (12)

Mean SMBG
Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.
Measured: 8 weeks for each treatment
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Measured: 8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values
Measured: Baseline, 8 weeks for each treatment
Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%
Measured: 8 weeks for each treatment
Percentage of Participants With Hyperglycemia
Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 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.
Measured: 8 weeks for each treatment
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 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.
Measured: 8 weeks for each treatment
Percentage of Participants With Pump Complications
Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; 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 change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
Measured: 8 weeks for each treatment
Pump Complication Rate Per 30 Days
Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; 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 change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
Measured: 8 weeks for each treatment
Percentage of Participants With Hypoglycemia
Hypoglycemia was defined as an event which was associated with
1. reported signs and symptoms of hypoglycemia, and/or
2. a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L).
Measured: 8 weeks for each treatment
Hypoglycemia Episode Rate Per 30 Days
Hypoglycemia was defined as an event which was associated with
1. reported signs and symptoms of hypoglycemia, and/or
2. a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days.
Measured: 8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight
Measured: Baseline, 8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure
Measured: Baseline, 8 weeks for each treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Aug 2011

First posted23 Apr 2010 (estimated)
Study startApr 2010
Primary completionAug 2011
Study completionAug 2011

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.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01109316
Sponsor's protocol ID: 12174
Other IDs: F3Z-MC-IOPV
Status last verified: Mar 2019
First submitted: 19 Apr 2010
Last updated: 27 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01109316
Acronym / sponsor ID: 12174
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 23 Apr 2010 (estimated)
Results: Posted 30 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Insulin Lispro 2 Day	Active comparator	Drug: Insulin lispro 2 day reservoir in-use
Insulin Lispro 6 Day	Experimental	Drug: Insulin lispro 6 day reservoir in-use
Insulin Aspart 6 Day	Active comparator	Drug: Insulin aspart 6 day reservoir in-use

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months.
Treated with continuous subcutaneous insulin infusion therapy for the previous 6 months.
Mean total daily insulin dose for 3 days prior to screening equal to or less than 46 units/day using a 300-unit reservoir or less than or equal to 26 units/day using a 180 unit reservoir.
Baseline body mass index (BMI) less than or equal to 35.0 kg/m^2.
Baseline glycosylated hemoglobin (HbA1c) 5% to 9%.

Key exclusion criteria (18 listed)

Impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per deciliter [mg/dL]).
Legal blindness.
Have had any episode of hypoglycemic coma, seizures, or disorientation in the 12 months prior to screening.
Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose (BG) less than 45 mg/dL) 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.

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 lispro 2 day reservoir in-useAlso: LY275585, HumalogInsulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.	Drug	Insulin Lispro 2 Day
Insulin lispro 6 day reservoir in-useAlso: LY275585, HumalogInsulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.	Drug	Insulin Lispro 6 Day
Insulin aspart 6 day reservoir in-useInsulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.	Drug	Insulin Aspart 6 Day

Primary outcome

Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use
Time frame: 8 weeks of each treatment

12 secondary outcomes

Mean SMBG
Time frame: 8 weeks for each treatment
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Time frame: 8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values
Time frame: Baseline, 8 weeks for each treatment
Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%
Time frame: 8 weeks for each treatment
Percentage of Participants With Hyperglycemia
Time frame: 8 weeks for each treatment
Hyperglycemic Episode Rate Per 30 Days
Time frame: 8 weeks for each treatment
Percentage of Participants With Pump Complications
Time frame: 8 weeks for each treatment
Pump Complication Rate Per 30 Days
Time frame: 8 weeks for each treatment
Percentage of Participants With Hypoglycemia
Time frame: 8 weeks for each treatment
Hypoglycemia Episode Rate Per 30 Days
Time frame: 8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight
Time frame: Baseline, 8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure
Time frame: Baseline, 8 weeks for each treatment

Results and safety

Results posted to the registry on 30 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A (L2D/L6D/A6D)	22	22
Sequence B (L2D/A6D/L6D)	22	22
Sequence C (L6D/L2D/A6D)	22	19
Sequence D (L6D/A6D/L2D)	22	21
Sequence E (A6D/L2D/L6D)	22	20
Sequence F (A6D/L6D/L2D)	22	20

Primary outcome: Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use

Time frame: 8 weeks of each treatment. Mean (Standard Deviation). Unit: millimoles per liter (mmol/L)

Measure	Insulin Lispro 2 Day n = 119	Insulin Lispro 6 Day n = 116	Insulin Aspart 6 Day n = 117
Value	9.03 (2.17)	9.33 (2.31)	8.72 (1.82)

Insulin Lispro 6 Day vs Insulin Aspart 6 Day: Least Squares Mean Difference: 0.48 (95% CI 0.20 to 0.76)

Population analysed: All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 8 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Lispro 2 Day	3 of 122 (2.5%)	71 of 122 (58.2%)	Not reported
Insulin Lispro 6 Day	8 of 127 (6.3%)	68 of 127 (53.5%)	Not reported
Insulin Aspart 6 Day	10 of 124 (8.1%)	71 of 124 (57.3%)	Not reported

Limitations and caveats (from the sponsor): Input to primary endpoint measurements (SMBG) contained approximately 40% missing data. Several analyses to account for missing data have been conducted and results from these additional analyses were consistent with results of original analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am - 5pm Eastern (UTC/GMT - 5hrs, EST) study director

Eli Lilly and Company

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 18 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 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Oct 2012). 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?

Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use (time frame: 8 weeks of each treatment). 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 NCT01109316.

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 27 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.