Diabetes Mellitus, Type 2Phase 4NCT00664534

Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

A Phase 4 study testing Insulin Glargine and Insulin Lispro Premix (mid-mixture and low-mixture) in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 27 sites in 8 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

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast. Read more about this study

Who is it for?: Ages 30 to 74 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin Glargine and Insulin Lispro Premix (mid-mixture and low-mixture)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 344 participants
Where: 27 sitesin 8 countries
Study dates: Apr 2008to Nov 2010
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 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diabetes Mellitus, Type 2
have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at least 90 days prior to Visit 1
glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
regularly consume a light breakfast (less than 15% of total daily calorie intake)
capable and willing to follow the protocol
give written consent

Who cannot join

are taking a TZD whose country label does not allow in combination with insulin
are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
have a body mass index greater than 40 kg/m^2
have a history of severe hypoglycemia in past 24 weeks
are pregnant or may become pregnant
women who are breastfeeding

Show all 11Show fewer

have significant cardiac disease
have significant renal or liver disease
undergoing therapy for a malignancy
contraindications to study medications
have an irregular sleep/wake cycle

Trial locations and contacts

27 sites in 8 countries.

Country

City, postcode or hospital

27 sites in 8 countries

Spain5 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.
Alicante, 03114
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Badalona, 08915
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Madrid, 28040
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Palma de Mallorca, 07198
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Santa Cruz de Tenerife, 38320

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Egypt4 sites

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Alexandria
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Bāb al Lūq
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Cairo, 11562
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Heliopolis

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India4 sites

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Ahmedabad, 380006
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Hyderabaad, 500033
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Indore, 452001
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Mumbai, 400053

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Portugal4 sites

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Aveiro, 3814-501
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Barreiro, 2830
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Lisbon, 1250-203
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Porto, 4099-001

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Romania4 sites

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Bucharest, 020359
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Craiova, 200000
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Galati, 6200
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Iași, 70057

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Turkey (Türkiye)3 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.
Ankara, 06510
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.
Antalya, 07070
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Konya, 42075

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Mexico2 sites

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Coatzacoalcos, 96400
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Mexico City, 06700

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Canada1 site

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Smiths Falls, Ontario, K7A 4W8

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About this study

Official title: Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin Glargine, Insulin Lispro Premix (mid-mixture and low-mixture)
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 GlargineDrug
patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks
Insulin Lispro Premix (mid-mixture and low-mixture)Drug
Also called LY275585
patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks

Study groups in NCT00664534
Study group	Role	What they receive
Glargine	Active comparator	Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs) Receives: Drug: Insulin Glargine
Premixed Insulin Lispro	Experimental	Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs Receives: Drug: Insulin Lispro Premix (mid-mixture and low-mixture)

What is being measured

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

Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint
Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.
Measured: 48 weeks

Secondary outcomes (10)

Percentage of Participants Using Each Possible Final Insulin Regimen
Insulin Regimens:
Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro.
Measured: 48 weeks
HbA1c Over Time
Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population.
Measured: 16 weeks, 32 weeks, and 48 weeks
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Measured: 16 weeks, 32 weeks and 48 weeks
7-point Self-monitored Blood Glucose Profiles
Measured: 16 weeks, 32 weeks and 48 weeks
Mean Postprandial Blood Glucose Values
Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.
Measured: Baseline, 16 weeks, 32 weeks and 48 weeks
Mean Daily Total, Basal and Prandial Insulin Dose
Measured: 16 weeks, 32 weeks and 48 weeks
Body Weight Change From Baseline to Endpoint
Measured: baseline, 48 weeks
Incidence of All Self-reported Hypoglycemic Episodes
Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).
Measured: Baseline to 48 weeks
Rate Per 30 Days of All Self-reported Hypoglycemic Episodes
The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).
Measured: Baseline to 48 weeks
Number of Participants With Adverse Events
A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.
TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline.
Measured: Baseline to 48 weeks

Timeline

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

Apr 2008Nov 2010

First posted23 Apr 2008 (estimated)
Study startApr 2008
Primary completionNov 2010
Study completionNov 2010

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 2Studies 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: 344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00664534
Sponsor's protocol ID: 11806
Other IDs: F3Z-EW-S020, CTRI/2009/091/000609
Status last verified: Nov 2011
First submitted: 21 Apr 2008
Last updated: 13 Dec 2011
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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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast
ClinicalTrials.gov ID: NCT00664534
Acronym / sponsor ID: 11806
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 344 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 23 Apr 2008 (estimated)
Results: Posted 13 Dec 2011

Clinical summary

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

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Study design

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

Arm	Type	Receives
Glargine	Active comparator	Drug: Insulin GlargineGlargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
Premixed Insulin Lispro	Experimental	Drug: Insulin Lispro Premix (mid-mixture and low-mixture)Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs

Who may qualify

Ages: 30 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diabetes Mellitus, Type 2
have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at least 90 days prior to Visit 1
glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
regularly consume a light breakfast (less than 15% of total daily calorie intake)
capable and willing to follow the protocol

Key exclusion criteria (11 listed)

are taking a TZD whose country label does not allow in combination with insulin
are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
have a body mass index greater than 40 kg/m^2
have a history of severe hypoglycemia in past 24 weeks
are pregnant or may become pregnant

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 Glarginepatient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks	Drug	Glargine
Insulin Lispro Premix (mid-mixture and low-mixture)Also: LY275585patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks	Drug	Premixed Insulin Lispro

Primary outcome

Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint
Time frame: 48 weeks
Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.

10 secondary outcomes

Percentage of Participants Using Each Possible Final Insulin Regimen
Time frame: 48 weeks
HbA1c Over Time
Time frame: 16 weeks, 32 weeks, and 48 weeks
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time
Time frame: 16 weeks, 32 weeks and 48 weeks
7-point Self-monitored Blood Glucose Profiles
Time frame: 16 weeks, 32 weeks and 48 weeks
Mean Postprandial Blood Glucose Values
Time frame: Baseline, 16 weeks, 32 weeks and 48 weeks
Mean Daily Total, Basal and Prandial Insulin Dose
Time frame: 16 weeks, 32 weeks and 48 weeks
Body Weight Change From Baseline to Endpoint
Time frame: baseline, 48 weeks
Incidence of All Self-reported Hypoglycemic Episodes
Time frame: Baseline to 48 weeks
Rate Per 30 Days of All Self-reported Hypoglycemic Episodes
Time frame: Baseline to 48 weeks
Number of Participants With Adverse Events
Time frame: Baseline to 48 weeks

Results and safety

Results posted to the registry on 13 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glargine	173	132
Premix Insulin Lispro	171	138

Primary outcome: Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint

Time frame: 48 weeks. Least squares mean (95% Confidence Interval). Unit: percent glycosylated hemoglobin

Measure	Glargine n = 98	Premix Insulin Lispro n = 108
Value	7.55 (7.27 to 7.82)	7.40 (7.15 to 7.65)

Glargine vs Premix Insulin Lispro: Least squares mean difference: -0.14 (95% CI -0.42 to 0.13)

Population analysed: PP Population=All participants who were randomized and met following criteria during study: * no violations of Inclusion/Exclusion Criteria * no early study discontinuation * compliant with treatment * received no other antihyperglycemic medication than allowed in Protocol, and have not been on systemic glucocorticoids for \>14 consecutive days.

10 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
Premix Insulin Lispro	7 of 169 (4.1%)	52 of 169 (30.8%)	Not reported
Glargine	3 of 173 (1.7%)	53 of 173 (30.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Diabetes Mellitus, Type 2

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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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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

27 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Glargine and Insulin Lispro Premix (mid-mixture and low-mixture) in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 27 sites in 8 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 6 inclusion and 11 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 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain, Egypt, India, Portugal, Romania and 3 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 13 Dec 2011). 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?

Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint (time frame: 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 NCT00664534.

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 13 Dec 2011.