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Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Insulin Lispro Mix25

Insulin Lispro Mix50

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Insulin Lispro Mix25

Insulin Lispro Mix50

Arm Description

Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.

Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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].

Insulin Dose at Week 26

Insulin dose is the total daily dose including basal and prandial doses.

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.

Full Information

NCT ID

NCT01773473

First Posted

January 18, 2013

Last Updated

May 4, 2015

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01773473

Brief Title

Comparison of Insulin Mix25 Versus Mix50

Acronym

CLASSIFY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

403 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin Lispro Mix25

Arm Type

Experimental

Arm Description

Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.

Arm Title

Insulin Lispro Mix50

Arm Type

Experimental

Arm Description

Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro Mix25

Other Intervention Name(s)

LY275585-75

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro Mix50

Other Intervention Name(s)

LY275585-50

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 26

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26

Description

Time Frame

Baseline through Week 26

Title

Change From Baseline in Fasting Blood Glucose (FBG) at Week 26

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in Body Weight at Week 26

Description

Time Frame

Baseline, Week 26

Title

Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)

Description

Time Frame

Baseline through Week 26

Title

Insulin Dose at Week 26

Description

Insulin dose is the total daily dose including basal and prandial doses.

Time Frame

Week 26

Title

Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26

Description

Time Frame

Baseline, Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Beijing

ZIP/Postal Code

100029

Country

China

Facility Name

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

City

Chongqing

ZIP/Postal Code

404000

Country

China

Facility Name

City

Nanjing

ZIP/Postal Code

210028

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200092

Country

China

Facility Name

City

Wulumuqi

ZIP/Postal Code

830000

Country

China

Facility Name

City

Zhengzhou

ZIP/Postal Code

450052

Country

China

Facility Name

City

Ibaraki

ZIP/Postal Code

302-0118

Country

Japan

Facility Name

City

Kagoshima

ZIP/Postal Code

895-0052

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

242-0004

Country

Japan

Facility Name

City

Miyagi

ZIP/Postal Code

985-0835

Country

Japan

Facility Name

City

Nagano

ZIP/Postal Code

399-0006

Country

Japan

Facility Name

City

Okayama

ZIP/Postal Code

700-0013

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

City

Saitama

ZIP/Postal Code

350-1305

Country

Japan

Facility Name

City

Tochigi

ZIP/Postal Code

329-0433

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

206-0633

Country

Japan

Facility Name

City

Yamaguchi

ZIP/Postal Code

751-0815

Country

Japan

Facility Name

City

Daejeon

ZIP/Postal Code

302-799

Country

Korea, Republic of

Facility Name

City

Incheon

ZIP/Postal Code

403-720

Country

Korea, Republic of

Facility Name

City

Jeju Special Self-Governing Pr

ZIP/Postal Code

690-767

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

City

Suwon

ZIP/Postal Code

442-723

Country

Korea, Republic of

Facility Name

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

City

Gaziantep

ZIP/Postal Code

27070

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

29574635

Citation

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.

Results Reference

derived

Learn more about this trial

Comparison of Insulin Mix25 Versus Mix50

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