NCT02302716|CompletedPhase 3Results

A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus

ELEMENT 5

A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to LANTUS® in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 5 Study

Eli Lilly and Company ClinicalTrials.gov

Compare

2 other identifiers

15615I4L-MC-ABER

Study Type

interventional

Target

493

Locations

7 countries

Sites

Timeline

RegisteredNov 2014

StartedDec 2014

CompletionJul 2016

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).

Trial Health

On Track

Trial Health Score

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

Enrollment

493

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Dec 2014

Geographic Reach

7 countries

44 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

First Submitted

Initial submission to the registry

November 25, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed

4 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

October 24, 2017

Completed

Last Updated

October 24, 2017

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

November 25, 2014

Results QC Date

September 25, 2017

Last Update Submit

September 25, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit\*treatment in the model.
Baseline, 24 weeks

Secondary Outcomes (10)

Percentage of Participants With HbA1c <7% and ≤6.5%
Endpoint [up to 24 weeks]
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Baseline, Week 24
Intra-Participant Variability in Fasting Blood Glucose (FBG)
Week 24
Basal Insulin Dose Units Per Day
Week 24
Basal Insulin Dose Per Body Weight (U/kg/Day)
Week 24
+5 more secondary outcomes

Study Arms (2)

LY2963016

EXPERIMENTAL

Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine hagedorn (NPH) QD will begin the study at their current dose SC. Participants will self titrate LY2963016 based on fasting blood glucose (FBG). Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will continue oral antihyperglycemic medication (OAM).

Drug: LY2963016Drug: Oral Antihyperglycemic Medication

LANTUS®

ACTIVE COMPARATOR

Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD will be started at the same dose SC. Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will self titrate LANTUS® based on FBG. Participants will continue OAM.

Drug: LANTUS®Drug: Oral Antihyperglycemic Medication

Interventions

LY2963016DRUG

Administered SC

LY2963016

LANTUS®DRUG

Administered SC

LANTUS®

Oral Antihyperglycemic MedicationDRUG

Administered as per standard-of-care.

LANTUS®LY2963016

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Have type 2 diabetes mellitus (T2DM).
Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening, with or without basal insulin.
If currently on basal insulin, must be taking LANTUS® QD or NPH or insulin detemir either QD or twice a day for at least 90 days prior to study entry.
Have an HbA1c ≥7.0% and ≤11.0% if insulin naïve; if previously on basal insulin, then HbA1c ≤11.0%.
Body mass index (BMI) ≤45 kilograms per meter squared (kg/m\^2).
As determined by the investigator, are capable and willing to do the following:
perform self monitored blood glucose (SMBG)
complete participant diaries as instructed
are receptive to diabetes education
comply with required study treatment and study visits

You may not qualify if:

Have been on LANTUS® more than once daily within the previous 30 days.
Have used any other insulin except the entry insulin \[LANTUS®, insulin detemir, or NPH\] including commercial (includes any premixed insulins) and investigational insulins within the previous 30 days.
Have been exposed to a biosimilar insulin glargine within the previous 90 days.
Have participated in a LY2963016 study.
Have taken basal plus mealtime insulin (basal bolus therapy) within the last year for greater than 4 continuous weeks.
Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
Have used pramlintide within the previous 30 days.
Have excessive insulin resistance at study entry (total insulin dose ≥1.5 units/kg).
Have more than 1 episode of severe hypoglycemia within 6 months prior to screening.
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
Have known hypersensitivity or allergy to LANTUS® or its excipients.
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy or have received such therapy within 4 weeks immediately preceding screening.
Have obvious signs or symptoms, or laboratory evidence, of liver disease.
Have one of the following concomitant diseases: significant cardiac (e.g., congestive heart failure Class III or IV) or gastrointestinal disease (e.g., significant gastroparesis).
Have a history of renal transplantation or are currently receiving renal dialysis.
+8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Boehringer Ingelheimcollaborator

Study Sites (44)

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Atlanta Vanguard Medical Associates

Smyrna, Georgia, 30082, United States

Location

Cotton O'Neil Clinic

Topeka, Kansas, 66606, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Dallas Diabetes Endocrine Center

Dallas, Texas, 75230, United States

Location

Advanced Research Institute

South Ogden, Utah, 84405, United States

Location

Tacoma Center for Arthritis Research, PS

Tacoma, Washington, 98405, United States

Location

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.

Ahmedabad, 380007, India

Location

Chennai, 600086, India

Location

Hyderabad, 500 012, India

Location

Jaipur, 302020, India

Location

Kormangala, 560034, India

Location

Mumbai, 40016, India

Location

New Delhi, 110060, India

Location

Panjim, 403001, India

Location

Pune, 411001, India

Location

Secunderabad, 500033, India

Location

Visakhapatnam, 530002, India

Location

Manati Center for Clinical Research Inc

Manatí, 00674, Puerto Rico

Location

American Telemedicine Center

San Juan, 00917, Puerto Rico

Location

Cheboksary, 428000, Russia

Location

Saint Petersburg, 192012, Russia

Location

Saratov, 410053, Russia

Location

Ansan-si, 425-707, South Korea

Location

Bucheon-si, 420-717, South Korea

Location

Daegu, 700-712, South Korea

Location

Goyang, 411-706, South Korea

Location

Goyang-si, 410-719, South Korea

Location

Jeju City, 690-767, South Korea

Location

Pusan, 602-739, South Korea

Location

Seoul, 139-872, South Korea

Location

Suwon, 442-723, South Korea

Location

Sindian City, 23148, Taiwan

Location

Taichung, 40201, Taiwan

Location

Taichung, 40447, Taiwan

Location

Taichung, 433, Taiwan

Location

Taipei, 10508, Taiwan

Location

Ankara, 6110, Turkey (Türkiye)

Location

Antalya, 07059, Turkey (Türkiye)

Location

Gaziantep, 27310, Turkey (Türkiye)

Location

Istanbul, 34865, Turkey (Türkiye)

Location

Related Publications (2)

Mohan V, Ahn KJ, Cho YM, Sahay RK, Huang CN, Kalra S, Chadha M, Bhattacharya I, Kim SY, Spaepen E. Lilly Insulin Glargine Versus Lantus(R) in Type 2 Diabetes Mellitus Patients: India and East Asia Subpopulation Analyses of the ELEMENT 5 Study. Clin Drug Investig. 2019 Aug;39(8):745-756. doi: 10.1007/s40261-019-00798-1.
PMID: 31119716DERIVED
Pollom RK, Ilag LL, Lacaya LB, Morwick TM, Ortiz Carrasquillo R. Lilly Insulin Glargine Versus Lantus(R) in Insulin-Naive and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5). Diabetes Ther. 2019 Feb;10(1):189-203. doi: 10.1007/s13300-018-0549-3. Epub 2019 Jan 2.
PMID: 30604091DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2963016 insulin glargineInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Chief 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 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

December 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 24, 2017

Results First Posted

October 24, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing: Will share

Locations

RU(3)KR(9)PR(2)TW(5)TU(4)US(10)IN(11)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

LY2963016

LANTUS®

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (44)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations