Type 2 Diabetes MellitusPhase 4CLASSIFYNCT01773473

Comparison of Insulin Mix25 Versus Mix50

A Phase 4 study testing Insulin Lispro Mix25 and Insulin Lispro Mix50 in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 27 sites in 4 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 determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Insulin Lispro Mix25 and Insulin Lispro Mix50
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 403 participants
Where: 27 sitesin 4 countries
Study dates: Jan 2013to Aug 2014
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months
Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these
Have a qualifying hemoglobin A1c (HbA1C) value ≥7.0% and ≤11.0% at screening
Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m²)
Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site

Who cannot join

Have a diagnosis of type 1 diabetes
Have had more than 1 episode of severe hypoglycemia within the 6 months before screening
Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory
Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula <30 milliliter per minute (mL/min), as determined by the central laboratory at screening
Have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator

Show all 9Show fewer

Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years
Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Trial locations and contacts

27 sites in 4 countries.

Country

City, postcode or hospital

27 sites in 4 countries

Japan11 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.
Ibaraki, 302-0118
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Kagoshima, 895-0052
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Kanagawa, 242-0004
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Miyagi, 985-0835
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Nagano, 399-0006
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Okayama, 700-0013
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Osaka, 530-0001
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Saitama, 350-1305
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Tochigi, 329-0433
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Tokyo, 206-0633
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Yamaguchi, 751-0815

Other trials in Japan

China8 sites

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Beijing, 100029
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Changsha, 410013
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Chengdu, 610041
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Chongqing, 404000
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Nanjing, 210028
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Shanghai, 200092
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Ürümqi, 830000
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Zhengzhou, 450052

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South Korea5 sites

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Daejeon, 302-799
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Incheon, 403-720
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Jeju Special Self-Governing Pr, 690-767
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Seoul, 137-701
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Suwon, 442-723

Other trials in South Korea

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, 06500
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Antalya, 07070
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Gaziantep, 27070

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)

Conditions: Type 2 Diabetes Mellitus
Being tested: Insulin Lispro Mix25, Insulin Lispro Mix50
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 Mix25Drug
Also called LY275585-75
Administered SC
Insulin Lispro Mix50Drug
Also called LY275585-50
Administered SC

Study groups in NCT01773473
Study group	Role	What they receive
Insulin Lispro Mix25	Experimental	Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks. Receives: Drug: Insulin Lispro Mix25
Insulin Lispro Mix50	Experimental	Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks. Receives: Drug: Insulin Lispro Mix50

What is being measured

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

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.
Measured: Baseline, Week 26

Secondary outcomes (6)

Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.
Measured: Baseline through Week 26
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect.
Measured: Baseline, Week 26
Change From Baseline in Body Weight at Week 26
LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.
Measured: Baseline, Week 26
Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)
A hypoglycemic event 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 BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005].
Measured: Baseline through Week 26
Insulin Dose at Week 26
Insulin dose is the total daily dose including basal and prandial doses.
Measured: Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.
Measured: Baseline, Week 26

Timeline

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

Jan 2013Aug 2014

First posted23 Jan 2013 (estimated)
Study startJan 2013
Primary completionAug 2014
Study completionAug 2014

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: 403 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01773473
Sponsor's protocol ID: 14675
Other IDs: F3Z-CR-IOQI
Acronym: CLASSIFY
Status last verified: May 2015
First submitted: 18 Jan 2013
Last updated: 21 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Su Q, Liu J, Li P, Qian L, Yang W. Relative Contribution of Fasting and Postprandial Blood Glucose in Overall Glycemic Control: Post Hoc Analysis of a Phase IV Randomized Trial. Diabetes Ther. 2018 Jun;9(3):987-999. doi: 10.1007/s13300-018-0403-7. Epub 2018 Mar 24.
PubMed 29574635

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 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)
ClinicalTrials.gov ID: NCT01773473
Acronym / sponsor ID: CLASSIFY / 14675
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 23 Jan 2013 (estimated)
Results: Posted 21 May 2015

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 Mix25	Experimental	Drug: Insulin Lispro Mix25Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50	Experimental	Drug: Insulin Lispro Mix50Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.

Who may qualify

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

Key inclusion criteria (5 listed)

Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months
Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these
Have a qualifying hemoglobin A1c (HbA1C) value ≥7.0% and ≤11.0% at screening
Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m²)
Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site

Key exclusion criteria (9 listed)

Have a diagnosis of type 1 diabetes
Have had more than 1 episode of severe hypoglycemia within the 6 months before screening
Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory
Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula <30 milliliter per minute (mL/min), as determined by the central laboratory at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin Lispro Mix25Also: LY275585-75Administered SC	Drug	Insulin Lispro Mix25
Insulin Lispro Mix50Also: LY275585-50Administered SC	Drug	Insulin Lispro Mix50

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Time frame: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.

6 secondary outcomes

Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26
Time frame: Baseline through Week 26
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Body Weight at Week 26
Time frame: Baseline, Week 26
Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)
Time frame: Baseline through Week 26
Insulin Dose at Week 26
Time frame: Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
Time frame: Baseline, Week 26

Results and safety

Results posted to the registry on 21 May 2015, 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 Mix25	207	191
Insulin Lispro Mix50	196	177

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

Time frame: Baseline, Week 26. Least squares mean (95% Confidence Interval). Unit: percentage of glycosylated hemoglobin

Measure	Insulin Lispro Mix25 n = 192	Insulin Lispro Mix50 n = 179
Value	-1.52 (-1.66 to -1.39)	-1.69 (-1.83 to -1.55)

Insulin Lispro Mix25 vs Insulin Lispro Mix50: Mean Difference (Net): 0.17 (95% CI -0.01 to 0.35)

Population analysed: All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 HbA1c measurements.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Lispro Mix25	8 of 207 (3.9%)	87 of 207 (42%)	Not reported
Insulin Lispro Mix50	7 of 196 (3.6%)	84 of 196 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29574635Su Q, Liu J, Li P, Qian L, Yang W. Relative Contribution of Fasting and Postprandial Blood Glucose in Overall Glycemic Control: Post Hoc Analysis of a Phase IV Randomized Trial. Diabetes Ther. 2018 Jun;9(3):987-999. doi: 10.1007/s13300-018-0403-7. Epub 2018 Mar 24.

Related trials for Type 2 Diabetes Mellitus

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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 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Lispro Mix25 and Insulin Lispro Mix50 in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 27 sites in 4 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 9 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 21 May 2015. 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 Japan, China, South Korea, Turkey (Türkiye). 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 21 May 2015). 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 in Hemoglobin A1c (HbA1c) at Week 26 (time frame: Baseline, Week 26). 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 NCT01773473, 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 21 May 2015.