Diabetes Mellitus, Type 2Phase 4NCT01175811

A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus

A Phase 4 study testing Insulin Lispro Premix, Insulin Glargine and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 14 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

The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin Lispro Premix, 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: 402 participants
Where: 14 sitesin 3 countries
Study dates: Feb 2011to Nov 2012
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Present with type 2 diabetes mellitus
Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry
Have Haemoglobin A1c (HbA1c) >7.0% and <12.0%

Who cannot join

Within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications
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.
Are women who are breastfeeding.
Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night).
Do not regularly consume three meals per day.
Have a body mass index >35 kilogram per square meter (kg/m^2).

Show all 10Show fewer

Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study.
Have cardiac disease with a functional status that is Class III or IV
Have a history of renal or liver disease
Have used less than or equal to 20 Units per day (U/day) of insulin during the past 90 days for more than 14 days (accumulated).

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

China6 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, 100730
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, 510515
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.
Kunming, 650032
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.
Nanjing, 210109
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.
Shanghai, 200080
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.
Xi'an, 710032

Other trials in China

South Korea4 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.
Daegu, 705-718
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.
Goyang-si, 410-719
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, 130-702
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.
Yeongdeungpo-gu, 150-950

Other trials in South Korea

Taiwan4 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.
Changhua, 500
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.
Kuei Shan Hsiang, 33305
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.
Sindian City, 23148
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.
Yong Kung City, 71004

Other trials in Taiwan

About this study

Official title: A Comparison of Premixed and Basal-Bolus Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Twice-daily Premixed Insulin

The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin Lispro Premix, Insulin Glargine, Insulin Lispro
Keywords: Metabolic Diseases, Diabetes Mellitus, Type 2, Glargine, Diabetes Mellitus, Insulin LISPRO, Insulin
Medical subject headings: Diabetes Mellitus, Type 2, Metabolic Diseases, Diabetes Mellitus, Insulin Resistance

What participants receive

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

Insulin Lispro PremixDrug
Also called Humalog Mix25, Humalog Mix50, LY275585
Participant dependent dose, administered subcutaneously for 24 weeks
Insulin GlargineDrug
Participant dependent dose, administered subcutaneously for 24 weeks
Insulin LisproDrug
Also called Humalog, LY275585
Participant dependent dose, administered subcutaneously for 24 weeks

Study groups in NCT01175811
Study group	Role	What they receive
Premixed Insulin	Experimental	Twice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension [LM50]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension [LM25]) Receives: Drug: Insulin Lispro Premix
Basal-Bolus	Active comparator	Once daily (bedtime) insulin glargine and three pre-meal 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 in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Measured: Baseline, 24 weeks

Secondary outcomes (9)

Change in HbA1c From Baseline to 12 Week Endpoint
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Measured: Baseline, 12 weeks
The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.
Measured: 12 weeks, 24 weeks
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.
Measured: Baseline, 12 weeks, and 24 weeks
Daily Dose of Insulin: Total, Basal, and Prandial
Measured: 24 weeks
Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.
Measured: Baseline, 12 weeks, and 24 weeks
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
Measured: 24 weeks
Percentage of Participants With Hypoglycemic Episodes (Incidence)
Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).
Measured: baseline through 24 weeks
The Rate of Hypoglycemic Episodes
The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).
Measured: baseline through 24 weeks
Percentage of Participants Experiencing a Severe Hypoglycemic Episode
Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.
Measured: baseline through 24 weeks

Timeline

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

Feb 2011Nov 2012

First posted5 Aug 2010 (estimated)
Study startFeb 2011
Primary completionNov 2012
Study completionNov 2012

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 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: 402 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01175811
Sponsor's protocol ID: 13492
Other IDs: F3Z-CR-IOQD
Status last verified: Oct 2013
First submitted: 3 Aug 2010
Last updated: 18 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jia W, Xiao X, Ji Q, Ahn KJ, Chuang LM, Bao Y, Pang C, Chen L, Gao F, Tu Y, Li P, Yang J. Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in east Asian patients with type 2 diabetes insufficiently controlled with twice-daily premixed insulin: an open-label, randomised, controlled trial. Lancet Diabetes Endocrinol. 2015 Apr;3(4):254-62. doi: 10.1016/S2213-8587(15)00041-8. Epub 2015 Mar 6.
PubMed 25754414

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 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Premixed and Basal-Bolus Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Twice-daily Premixed Insulin
ClinicalTrials.gov ID: NCT01175811
Acronym / sponsor ID: 13492
Conditions: Diabetes Mellitus, Type 2
Keywords: Metabolic Diseases, Diabetes Mellitus, Type 2, Glargine, Diabetes Mellitus, Insulin LISPRO, Insulin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 402 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 5 Aug 2010 (estimated)
Results: Posted 18 Dec 2013

Clinical summary

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

The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

Study design

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

Arm	Type	Receives
Premixed Insulin	Experimental	Drug: Insulin Lispro PremixTwice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension [LM50]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension [LM25])
Basal-Bolus	Active comparator	Drug: Insulin Glargine, Drug: Insulin LisproOnce daily (bedtime) insulin glargine and three pre-meal insulin lispro

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Present with type 2 diabetes mellitus
Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry
Have Haemoglobin A1c (HbA1c) >7.0% and <12.0%

Key exclusion criteria (10 listed)

Within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications
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.
Are women who are breastfeeding.
Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night).
Do not regularly consume three meals per day.

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 PremixAlso: Humalog Mix25, Humalog Mix50, LY275585Participant dependent dose, administered subcutaneously for 24 weeks	Drug	Premixed Insulin
Insulin GlargineParticipant dependent dose, administered subcutaneously for 24 weeks	Drug	Basal-Bolus
Insulin LisproAlso: Humalog, LY275585Participant dependent dose, administered subcutaneously for 24 weeks	Drug	Basal-Bolus

Primary outcome

Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.

9 secondary outcomes

Change in HbA1c From Baseline to 12 Week Endpoint
Time frame: Baseline, 12 weeks
The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
Time frame: 12 weeks, 24 weeks
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
Time frame: Baseline, 12 weeks, and 24 weeks
Daily Dose of Insulin: Total, Basal, and Prandial
Time frame: 24 weeks
Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
Time frame: 24 weeks
Percentage of Participants With Hypoglycemic Episodes (Incidence)
Time frame: baseline through 24 weeks
The Rate of Hypoglycemic Episodes
Time frame: baseline through 24 weeks
Percentage of Participants Experiencing a Severe Hypoglycemic Episode
Time frame: baseline through 24 weeks

Results and safety

Results posted to the registry on 18 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Premixed Insulin	199	183
Basal-Bolus	203	189

Primary outcome: Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint

Time frame: Baseline, 24 weeks. Least squares mean (95% Confidence Interval). Unit: percent HbA1c

Measure	Premixed Insulin n = 197	Basal-Bolus n = 202
Value	-1.05 (-1.19 to -0.92)	-1.06 (-1.19 to -0.93)

Premixed Insulin vs Basal-Bolus: LSmean difference: 0.01 (95% CI -0.14 to 0.16)

Population analysed: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.

9 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
Premixed Insulin	13 of 197 (6.6%)	60 of 197 (30.5%)	Not reported
Basal-Bolus	8 of 202 (4%)	60 of 202 (29.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25754414Jia W, Xiao X, Ji Q, Ahn KJ, Chuang LM, Bao Y, Pang C, Chen L, Gao F, Tu Y, Li P, Yang J. Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in east Asian patients with type 2 diabetes insufficiently controlled with twice-daily premixed insulin: an open-label, randomised, controlled trial. Lancet Diabetes Endocrinol. 2015 Apr;3(4):254-62. doi: 10.1016/S2213-8587(15)00041-8. Epub 2015 Mar 6.

Related trials for Diabetes Mellitus, Type 2

Active, not recruitingPhase 2
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Lispro Premix, Insulin Glargine and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 14 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 3 inclusion and 10 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China, South Korea, Taiwan. 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 18 Dec 2013). 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 Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint (time frame: Baseline, 24 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 NCT01175811, 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 18 Dec 2013; AzTrials last refreshed its copy on 3 Nov 2026.