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

NCT ID: NCT02302716

Last Updated: 2017-10-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

493 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY2963016

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).

Group Type EXPERIMENTAL

LY2963016

Intervention Type DRUG

Administered SC

Oral Antihyperglycemic Medication

Intervention Type DRUG

Administered as per standard-of-care.

LANTUS®

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.

Group Type ACTIVE_COMPARATOR

LANTUS®

Intervention Type DRUG

Administered SC

Oral Antihyperglycemic Medication

Intervention Type DRUG

Administered as per standard-of-care.

Interventions

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LY2963016

Administered SC

Intervention Type DRUG

LANTUS®

Administered SC

Intervention Type DRUG

Oral Antihyperglycemic Medication

Administered as per standard-of-care.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* Have a serum creatinine greater than 2.0 milligrams/deciliter (177 micromoles/liter).
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
* Participants with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ).
* Have a history or diagnosis of Human Immunodeficiency Virus (HIV) infection.
* Have any other condition (including known drug or alcohol abuse or psychiatric disorder including dementia) that precludes the participant from following and completing the protocol.
* Are pregnant or intend to become pregnant during the course of the study.
* Women who are breastfeeding.
* 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 other than LY2963016, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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New Horizon Research Center

Miami, Florida, United States

Site Status

Suncoast Clinical Research

New Port Richey, Florida, United States

Site Status

Atlanta Vanguard Medical Associates

Smyrna, Georgia, United States

Site Status

Cotton O'Neil Clinic

Topeka, Kansas, United States

Site Status

Manhattan Medical Research

New York, New York, United States

Site Status

Aventiv Research

Columbus, Ohio, United States

Site Status

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, United States

Site Status

Dallas Diabetes Endocrine Center

Dallas, Texas, United States

Site Status

Advanced Research Institute

South Ogden, Utah, United States

Site Status

Tacoma Center for Arthritis Research, PS

Tacoma, Washington, United States

Site Status

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, , India

Site Status

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.

Chennai, , India

Site Status

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Hyderabad, , India

Site Status

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Jaipur, , India

Site Status

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Kormangala, , India

Site Status

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Mumbai, , India

Site Status

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New Delhi, , India

Site Status

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Panjim, , India

Site Status

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Pune, , India

Site Status

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Secunderabad, , India

Site Status

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Visakhapatnam, , India

Site Status

Manati Center for Clinical Research Inc

Manatí, , Puerto Rico

Site Status

American Telemedicine Center

San Juan, , Puerto Rico

Site Status

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.

Cheboksary, , Russia

Site Status

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Saint Petersburg, , Russia

Site Status

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Saratov, , Russia

Site Status

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Ansan-si, , South Korea

Site Status

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Bucheon-si, , South Korea

Site Status

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Daegu, , South Korea

Site Status

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Goyang, , South Korea

Site Status

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Goyang-si, , South Korea

Site Status

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Jeju City, , South Korea

Site Status

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Pusan, , South Korea

Site Status

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Seoul, , South Korea

Site Status

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Suwon, , South Korea

Site Status

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Sindian City, , Taiwan

Site Status

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Taichung, , Taiwan

Site Status

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Taichung, , Taiwan

Site Status

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Taichung, , Taiwan

Site Status

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.

Taipei, , Taiwan

Site Status

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, , Turkey (Türkiye)

Site Status

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Antalya, , Turkey (Türkiye)

Site Status

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.

Gaziantep, , Turkey (Türkiye)

Site Status

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.

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States India Puerto Rico Russia South Korea Taiwan Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 31119716 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30604091 (View on PubMed)

Related Links

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http://www.lillytrialguide.com/EN/studies/diabetes/aber

Click here for more information about this study: A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus

Other Identifiers

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I4L-MC-ABER

Identifier Type: OTHER

Identifier Source: secondary_id

15615

Identifier Type: -

Identifier Source: org_study_id