Diabetes Mellitus, Type 1Phase 3NCT01134107

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

A Phase 3 study testing Insulin Lispro 6 Day (6D) and Insulin Aspart 6 Day (6D) in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 15 sites in 3 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 13 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Insulin Lispro 6 Day (6D) and Insulin Aspart 6 Day (6D)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 15 sitesin 3 countries
Study dates: Nov 2010to Dec 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 (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%

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 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.

Show all 17Show 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.
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.

Trial locations and contacts

15 sites in 3 countries.

Country

City, postcode or hospital

15 sites in 3 countries

France6 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.
Caen, 14033
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, 91106
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, 17019
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, 13009
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, 34295
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, 11108

Other trials in France

Germany5 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.
Ludwigshafen, 67059
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, 55116
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, 48145
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, 56564
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, 14469

Other trials in Germany

Hungary4 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.
Békéscsaba, 5600
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, 1023
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.
Nyíregyháza, 4400
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, 8900

Other trials in Hungary

About this study

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

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.

Conditions: Diabetes Mellitus, Type 1
Being tested: Insulin Lispro 6 Day (6D), Insulin Aspart 6 Day (6D)
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 6 Day (6D)Drug
Also called Insulin Lispro Formulation, Humalog, LY275585
Administered by infusion pump for 12 week treatment period
Insulin Aspart 6 Day (6D)Drug
Administered by infusion pump for 12 week treatment period

Study groups in NCT01134107
Study group	Role	What they receive
Insulin Lispro 6 Day (6D)	Experimental	Not described Receives: Drug: Insulin Lispro 6 Day (6D)
Insulin Aspart 6 Day (6D)	Active comparator	Not described Receives: Drug: Insulin Aspart 6 Day (6D)

What is being measured

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

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

Secondary outcomes (4)

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.
Measured: Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Measured: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
Measured: Baseline, endpoint for each 12-week treatment period
Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%
Measured: Endpoint for each 12-week treatment period

Timeline

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

Nov 2010Dec 2011

First posted31 May 2010 (estimated)
Study startNov 2010
Primary completionDec 2011
Study completionDec 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01134107
Sponsor's protocol ID: 12175
Other IDs: F3Z-MC-IOPW
Status last verified: Apr 2013
First submitted: 27 May 2010
Last updated: 11 Apr 2013
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?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01134107
Acronym / sponsor ID: 12175
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 31 May 2010 (estimated)
Results: Posted 26 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: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Insulin Lispro 6 Day (6D)	Experimental	Drug: Insulin Lispro 6 Day (6D)
Insulin Aspart 6 Day (6D)	Active comparator	Drug: Insulin Aspart 6 Day (6D)

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 (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%

Key exclusion criteria (17 listed)

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.

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 6 Day (6D)Also: Insulin Lispro Formulation, Humalog, LY275585Administered by infusion pump for 12 week treatment period	Drug	Insulin Lispro 6 Day (6D)
Insulin Aspart 6 Day (6D)Administered by infusion pump for 12 week treatment period	Drug	Insulin Aspart 6 Day (6D)

Primary outcome

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)

4 secondary outcomes

Mean SMBG
Time frame: Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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
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

Results and safety

Results posted to the registry on 26 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
Lispro 6D/Aspart 6D	67	61
Aspart 6D/Lispro 6D	66	61

Primary outcome: 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). Mean (Standard Deviation). Unit: millimoles per liter (mmol/L)

Measure	Insulin Lispro 6D n = 118	Insulin Aspart 6D n = 118
Value	8.83 (1.55)	8.43 (1.97)

Insulin Lispro 6D vs Insulin Aspart 6D: Least Squares Mean Difference: 0.36 (95% CI 0.06 to 0.66)

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.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Lispro 6D	3 of 127 (2.4%)	34 of 127 (26.8%)	Not reported
Insulin Aspart 6D	7 of 127 (5.5%)	31 of 127 (24.4%)	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 were conducted and results from these additional analyses were consistent with results from the original analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1
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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

15 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Lispro 6 Day (6D) and Insulin Aspart 6 Day (6D) in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 15 sites in 3 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 5 inclusion and 17 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France, Germany, Hungary. 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 26 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 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)). 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 NCT01134107.

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 11 Apr 2013.