Type 2 Diabetes MellitusPhase 4NCT00548808

A Study for Type 2 Diabetic Patients

A Phase 4 study testing Insulin lispro low mixture, Insulin glargine and Insulin lispro in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 25 sites in 7 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 the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level Read more about this study

Who is it for?: Ages 30 to 79 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Insulin lispro low mixture, Insulin glargine and Insulin lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 426 participants
Where: 25 sitesin 7 countries
Study dates: Nov 2007to Aug 2009
Phase: Phase 4
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 30 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus
Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
Able to perform self monitoring of blood glucose

Who cannot join

Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
Have a body mass index greater than 35 kg/m2
History or presence of kidney disease
Have cardiac disease (Class III or IV)

Trial locations and contacts

25 sites in 7 countries.

Country

City, postcode or hospital

25 sites in 7 countries

Canada6 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.
Charlottetown, Prince Edward Island, C1A 1L2
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.
Edmonton, Alberta, T5J 3N4
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Mississauga, Ontario, L5M 2V8
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Ottawa, Ontario, K1N 6N5
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Sherbrooke, Quebec, J1G 5K2
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Winnipeg, Manitoba, R3C 0N2

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India5 sites

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Aligarh, 202002
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Bangalore, 560052
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Coimbatore
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Mumbai, 400 007
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Trivandrum, 695029

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Brazil4 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.
Belém, 66073-000
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Campinas, 13073-350
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Curitiba, 80060-900
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Fortaleza, 60430-370

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Australia3 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.
Daw Park, South Australia, 5041
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East Ringwood, Victoria, 3135
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Nedlands, Western Australia, 6009

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China3 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.
Beijing, 100053
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.
Guangzhou, 510120
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Shanghai, 200433

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Mexico2 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.
Mexico City, 06700
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.
Monterrey, 64570

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South Korea2 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.
Kyunggi-Do, 425-020
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.
Seoul, 139-872

Other trials in South Korea

About this study

Official title: Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication

Conditions: Type 2 Diabetes Mellitus
Being tested: Insulin lispro low mixture, Insulin glargine, Insulin lispro
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

Insulin lispro low mixtureDrug
Also called LY275585[P]
Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
Insulin glargineDrug
Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
Insulin lisproDrug
Also called LY275585
Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.

Study groups in NCT00548808
Study group	Role	What they receive
Insulin lispro low mixture	Experimental	Insulin lispro low mixture (1, 2 or 3 daily injections) Receives: Drug: Insulin lispro low mixture
Insulin glargine	Active comparator	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro) Receives: Drug: Insulin glargine; Drug: Insulin lispro

What is being measured

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

Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
Measured: Baseline, 48 weeks

Secondary outcomes (8)

Change in Hemoglobin A1c (HbA1c) Over Time
Measured: Baseline, 16 Weeks, 32 Weeks, 48 Weeks
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Measured: 16 weeks, 32 weeks, 48 weeks
7-point Self-monitored Blood Glucose Profiles
Measured: Baseline, 16 weeks, 32 weeks, 48 weeks
Change From Baseline in Postprandial Blood Glucose Over Time
The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.
Measured: Baseline, 16 weeks, 32 weeks, 48 weeks
Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
Measured: 16 weeks, 32 weeks, 48 weeks
Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
Measured: 16 weeks, 32 weeks, 48 weeks
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
Measured: baseline, 48 weeks
Safety: Number of Participants With Serious and Non-Serious Adverse Events
Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.
Measured: baseline through 48 weeks

Timeline

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

Nov 2007Aug 2009

First posted24 Oct 2007 (estimated)
Study startNov 2007
Primary completionAug 2009
Study completionAug 2009

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 Type 2 Diabetes MellitusStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00548808
Sponsor's protocol ID: 11541
Other IDs: F3Z-CR-IOPH
Status last verified: Aug 2010
First submitted: 22 Oct 2007
Last updated: 15 Sep 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bowering K, Reed VA, Felicio JS, Landry J, Ji L, Oliveira J. A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet Med. 2012 Sep;29(9):e263-72. doi: 10.1111/j.1464-5491.2012.03722.x.
PubMed 22672081

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 Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication
ClinicalTrials.gov ID: NCT00548808
Acronym / sponsor ID: 11541
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 24 Oct 2007 (estimated)
Results: Posted 15 Sep 2010

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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin lispro low mixture	Experimental	Drug: Insulin lispro low mixtureInsulin lispro low mixture (1, 2 or 3 daily injections)
Insulin glargine	Active comparator	Drug: Insulin glargine, Drug: Insulin lisproInsulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Who may qualify

Ages: 30 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 diabetes mellitus
Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
Able to perform self monitoring of blood glucose

Key exclusion criteria (5 listed)

Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
Have a body mass index greater than 35 kg/m2
History or presence of kidney disease
Have cardiac disease (Class III or IV)

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 low mixtureAlso: LY275585[P]Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.	Drug	Insulin lispro low mixture
Insulin glargineDose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks	Drug	Insulin glargine
Insulin lisproAlso: LY275585Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.	Drug	Insulin glargine

Primary outcome

Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 48 weeks

8 secondary outcomes

Change in Hemoglobin A1c (HbA1c) Over Time
Time frame: Baseline, 16 Weeks, 32 Weeks, 48 Weeks
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Time frame: 16 weeks, 32 weeks, 48 weeks
7-point Self-monitored Blood Glucose Profiles
Time frame: Baseline, 16 weeks, 32 weeks, 48 weeks
Change From Baseline in Postprandial Blood Glucose Over Time
Time frame: Baseline, 16 weeks, 32 weeks, 48 weeks
Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
Time frame: 16 weeks, 32 weeks, 48 weeks
Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
Time frame: 16 weeks, 32 weeks, 48 weeks
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
Time frame: baseline, 48 weeks
Safety: Number of Participants With Serious and Non-Serious Adverse Events
Time frame: baseline through 48 weeks

Results and safety

Results posted to the registry on 15 Sep 2010, 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 LM	214	172
Insulin Glargine	212	186

Primary outcome: Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)

Time frame: Baseline, 48 weeks. Least squares mean (Standard Error). Unit: percent (%) glycated hemoglobin

Measure	Insulin Lispro LM n = 177	Insulin Glargine n = 184
Value	-1.91 (0.23)	-1.87 (0.23)

Insulin Lispro LM vs Insulin Glargine: Least Squares Mean Difference: -0.04 (95% CI -0.25 to 0.17), p = 0.716, ANCOVA

Population analysed: Per-protocol set: randomized, no entry criteria violations, completed \>=32 weeks of study, and no systemic glucocorticoid therapy for \>14 cumulative days during study. Last observation carried forward.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Lispro LM	19 of 211 (9%)	107 of 211 (50.7%)	Not reported
Insulin Glargine	13 of 212 (6.1%)	116 of 212 (54.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22672081Bowering K, Reed VA, Felicio JS, Landry J, Ji L, Oliveira J. A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet Med. 2012 Sep;29(9):e263-72. doi: 10.1111/j.1464-5491.2012.03722.x.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Type 2 Diabetes Mellitus

RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
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Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
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Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
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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

25 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin lispro low mixture, Insulin glargine and Insulin lispro in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 25 sites in 7 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 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 15 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Canada, India, Brazil, Australia, China and 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Sep 2010). 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 From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 48 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 NCT00548808, 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 15 Sep 2010; AzTrials last refreshed its copy on 1 Nov 2026.