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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

403

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline

Completed

Started Jan 2013

Geographic Reach

4 countries

27 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

January 1, 2013

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed

10 months until next milestone

Results Posted

Study results publicly available

May 21, 2015

Completed

Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

January 18, 2013

Results QC Date

May 4, 2015

Last Update Submit

May 4, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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.
Baseline, Week 26

Secondary Outcomes (6)

Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26
Baseline through Week 26
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
Baseline, Week 26
Change From Baseline in Body Weight at Week 26
Baseline, Week 26
Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)
Baseline through Week 26
Insulin Dose at Week 26
Week 26
+1 more secondary outcomes

Study Arms (2)

Insulin Lispro Mix25

EXPERIMENTAL

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

Drug: Insulin Lispro Mix25

Insulin Lispro Mix50

EXPERIMENTAL

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

Drug: Insulin Lispro Mix50

Interventions

Insulin Lispro Mix25DRUG

Administered SC

Also known as: LY275585-75

Insulin Lispro Mix25

Insulin Lispro Mix50DRUG

Administered SC

Also known as: LY275585-50

Insulin Lispro Mix50

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (27)

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, 100029, China

Location

Changsha, 410013, China

Location

Chengdu, 610041, China

Location

Chongqing, 404000, China

Location

Nanjing, 210028, China

Location

Shanghai, 200092, China

Location

Ürümqi, 830000, China

Location

Zhengzhou, 450052, China

Location

Ibaraki, 302-0118, Japan

Location

Kagoshima, 895-0052, Japan

Location

Kanagawa, 242-0004, Japan

Location

Miyagi, 985-0835, Japan

Location

Nagano, 399-0006, Japan

Location

Okayama, 700-0013, Japan

Location

Osaka, 530-0001, Japan

Location

Saitama, 350-1305, Japan

Location

Tochigi, 329-0433, Japan

Location

Tokyo, 206-0633, Japan

Location

Yamaguchi, 751-0815, Japan

Location

Daejeon, 302-799, South Korea

Location

Incheon, 403-720, South Korea

Location

Jeju Special Self-Governing Pr, 690-767, South Korea

Location

Seoul, 137-701, South Korea

Location

Suwon, 442-723, South Korea

Location

Ankara, 06500, Turkey (Türkiye)

Location

Antalya, 07070, Turkey (Türkiye)

Location

Gaziantep, 27070, Turkey (Türkiye)

Location

Related Publications (1)

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.
PMID: 29574635DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin lispro, isophane insulin lispro drug combination (25:75)

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title: Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 21, 2015

Results First Posted

May 21, 2015

Record last verified: 2015-05

Locations

CN(8)KR(5)JP(11)TU(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Insulin Lispro Mix25

Insulin Lispro Mix50

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations