Diabetes Mellitus, Type 1Phase 3IOOZNCT00487240

Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

A Phase 3 study testing Insulin Lispro Protamine Suspension and Insulin Levemir in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 28 sites in 9 countries.

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

The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Insulin Lispro Protamine Suspension and Insulin Levemir
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 387 participants
Where: 28 sitesin 9 countries
Study dates: Jun 2007to Aug 2008
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of type 1 diabetes for one year or more
Age 18 years or older
Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
As determined by the investigator, are capable and willing to do the following:
perform self monitoring of blood glucose (SMBG),

Show all 10Show fewer

complete patient diaries as required for this protocol,
use the insulin injection device(s) according to the instructions provided,
are receptive to diabetes education,
comply with the required study visits.

Who cannot join

Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
Are 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 or women who are breastfeeding
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Trial locations and contacts

28 sites in 9 countries.

Country

City, postcode or hospital

28 sites in 9 countries

Hungary5 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.
Budapest, 1088
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.
Mosonmagyaróvár, 9200
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Pécs, 7623
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Szentes, 6600
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Zalaegerszeg, 8900

Other trials in Hungary

United States4 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.
Idaho Falls, Idaho, 83404
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San Antonio, Texas, 78229
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Springfield, Illinois, 62704
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Topeka, Kansas, 66606

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Romania4 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.
Baia Mare, 430071
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Brasov, 500326
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Bucharest, 70266
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Iași, 6600

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Russia4 sites

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Arkhangelsk, 163045
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Moscow, 115478
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Rostov-on-Don, 344022
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Saint Petersburg, 193257

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Mexico3 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.
Guadalajara, 44600
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.
Pachuca, 42090
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Puebla City, 72160

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Argentina2 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.
Buenos Aires, C1213AAH
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 Plata, B1902AWL

Other trials in Argentina

Australia2 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.
Box Hill, Victoria, 3128
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.
Wollongong, New South Wales

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Brazil2 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.
Fortaleza, 60120-020
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.
São Paulo, 04020041

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Greece2 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.
Athens, 11527
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Thessaloniki, 56429

Other trials in Greece

About this study

Official title: Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes

Read the detailed description

Phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ILPS, also referred to as NPL [neutral protamine Hagedorn]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.

Conditions: Diabetes Mellitus, Type 1
Being tested: Insulin Lispro Protamine Suspension, Insulin Levemir
Keywords: diabetes, type 1
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin Lispro Protamine SuspensionDrug
Also called ILPS, NPL, Humalog, LY275585
Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.
Insulin LevemirDrug
Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks

Study groups in NCT00487240
Study group	Role	What they receive
Insulin Lispro Protamine Suspension	Experimental	Insulin Lispro Protamine Suspension twice daily Receives: Drug: Insulin Lispro Protamine Suspension
Detemir	Active comparator	Insulin Levemir (detemir) subcutaneous (SC) twice daily. Receives: Drug: Insulin Levemir

What is being measured

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

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Measured: baseline and 32 weeks

Secondary outcomes (10)

Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values
The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the "mean change from baseline" is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline.
Measured: Baseline, 8,16, 24, 32 Weeks
Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
Measured: 32 Weeks
7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint
Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.
Measured: 32 Weeks
Glycemic Variability at Endpoint
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
Measured: 32 Weeks
Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint
Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
Measured: Baseline to 32 Weeks
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
Measured: baseline to 32 weeks
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
Measured: baseline to 32 weeks
Change From Baseline in Absolute Body Weight at 32 Week Endpoint
Measured: Baseline, 32 Weeks
Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])
Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.
Measured: 32 Weeks
Insulin Dose (Total and By Component [Basal and Bolus])
Total daily insulin dose (U/day) was assessed.
Measured: 32 weeks

Timeline

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

Jun 2007Aug 2008

First posted18 Jun 2007 (estimated)
Study startJun 2007
Primary completionAug 2008
Study completionAug 2008

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.
Publications (1)Papers the sponsor has linked to this study.
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: Parallel groups
Masking: None (open label)
Enrolment: 387 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00487240
Sponsor's protocol ID: 10937
Other IDs: F3Z-MC-IOOZ
Acronym: IOOZ
Status last verified: Oct 2010
First submitted: 14 Jun 2007
Last updated: 4 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chacra AR, Kipnes M, Ilag LL, Sarwat S, Giaconia J, Chan J; COMPLETE T1D investigators. Comparison of insulin lispro protamine suspension and insulin detemir in basal-bolus therapy in patients with Type 1 diabetes. Diabet Med. 2010 May;27(5):563-9. doi: 10.1111/j.1464-5491.2010.02986.x.
PubMed 20536953

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 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT00487240
Acronym / sponsor ID: IOOZ / 10937
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes, type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 387 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 18 Jun 2007 (estimated)
Results: Posted 25 Sep 2009

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin Lispro Protamine Suspension	Experimental	Drug: Insulin Lispro Protamine SuspensionInsulin Lispro Protamine Suspension twice daily
Detemir	Active comparator	Drug: Insulin LevemirInsulin Levemir (detemir) subcutaneous (SC) twice daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Clinical diagnosis of type 1 diabetes for one year or more
Age 18 years or older
Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
As determined by the investigator, are capable and willing to do the following:

Key exclusion criteria (5 listed)

Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
Are 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 or women who are breastfeeding
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

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 Protamine SuspensionAlso: ILPS, NPL, Humalog, LY275585Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.	Drug	Insulin Lispro Protamine Suspension
Insulin LevemirPatient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks	Drug	Detemir

Primary outcome

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Time frame: baseline and 32 weeks

10 secondary outcomes

Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values
Time frame: Baseline, 8,16, 24, 32 Weeks
Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
Time frame: 32 Weeks
7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint
Time frame: 32 Weeks
Glycemic Variability at Endpoint
Time frame: 32 Weeks
Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint
Time frame: Baseline to 32 Weeks
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
Time frame: baseline to 32 weeks
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
Time frame: baseline to 32 weeks
Change From Baseline in Absolute Body Weight at 32 Week Endpoint
Time frame: Baseline, 32 Weeks
Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])
Time frame: 32 Weeks
Insulin Dose (Total and By Component [Basal and Bolus])
Time frame: 32 weeks

Results and safety

Results posted to the registry on 25 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Lispro Protamine Suspension	195	164
Detemir	192	166

Primary outcome: Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

Time frame: baseline and 32 weeks. Least squares mean (Standard Error). Unit: percent of HbA1c

Measure	Insulin Lispro Protamine Suspension n = 187	Detemir n = 185
Baseline	8.88 (0.10)	8.68 (0.10)
Change from Baseline	-0.69 (0.07)	-0.59 (0.07)

Insulin Lispro Protamine Suspension vs Detemir: Mean Difference (Net): -0.10 (95% CI -0.29 to 0.10), p = 0.332, ANCOVA

Population analysed: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Lispro Protamine Suspension	10 of ?	93 of ?	Not reported
Detemir	3 of ?	86 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20536953Chacra AR, Kipnes M, Ilag LL, Sarwat S, Giaconia J, Chan J; COMPLETE T1D investigators. Comparison of insulin lispro protamine suspension and insulin detemir in basal-bolus therapy in patients with Type 1 diabetes. Diabet Med. 2010 May;27(5):563-9. doi: 10.1111/j.1464-5491.2010.02986.x.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Diabetes Mellitus, Type 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

28 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Lispro Protamine Suspension and Insulin Levemir in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 28 sites in 9 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 10 inclusion and 5 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 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Hungary, United States, Romania, Russia, Mexico and 4 more countries. 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 25 Sep 2009). 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?

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint (time frame: baseline and 32 weeks). 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 NCT00487240, which also lists 1 linked publication.

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 4 Nov 2010.