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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: LY2963016 (Drug); LANTUS® (Drug); Oral Antihyperglycemic Medication (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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).

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)

Secondary outcome:

Percentage of Participants With HbA1c <7% and ≤6.5%

Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values

Intra-Participant Variability in FBG

Basal Insulin Dose

Change from Baseline to 24 Weeks in Body Weight

Insulin Treatment Satisfaction Questionnaire (ITSQ)

Proportion of Participants with Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®

Rate of Hypoglycemic Events Adjusted per 30 Days

Percentage of Participants with Hypoglycemic Events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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; Recruiting
Eli Lilly and Company

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 600086, India; Recruiting
Eli Lilly and Company

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., Hyderabad 500 012, India; Recruiting
Eli Lilly and Company

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., Kormangala 560034, India; Recruiting
Eli Lilly and Company

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., Mumbai 40016, India; Recruiting
Eli Lilly and Company

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., New Delhi 110060, India; Recruiting
Eli Lilly and Company

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., Panjim 403001, India; Recruiting
Eli Lilly and Company

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., Pune 411001, India; Recruiting
Eli Lilly and Company

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., Secunderabad 500033, India; Recruiting
Eli Lilly and Company

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., Visakhapatanam 530002, India; Recruiting
Eli Lilly and Company

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., Ansan-Si 425-707, Korea, Republic of; Recruiting
Eli Lilly and Company

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., Bucheon 420-717, Korea, Republic of; Recruiting
Eli Lilly and Company

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., Daegu 700-712, Korea, Republic of; Recruiting
Eli Lilly and Company

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., Goyang-Si 410-719, Korea, Republic of; Recruiting
Eli Lilly and Company

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., IlsanSeo Gu 411-706, Korea, Republic of; Recruiting
Eli Lilly and Company

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., Jeju 690-767, Korea, Republic of; Recruiting
Eli Lilly and Company

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., Pusan 602-739, Korea, Republic of; Recruiting
Eli Lilly and Company

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., Seoul 139-872, Korea, Republic of; Recruiting
Eli Lilly and Company

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., Suwon 442-723, Korea, Republic of; Recruiting
Eli Lilly and Company

Manati Center for Clinical Research Inc, Manati 00674, Puerto Rico; Recruiting
Phone: 7878541779
Ramon Ortiz-Carrasquillo, Principal Investigator

American Telemedicine Center, San Juan 00917, Puerto Rico; Recruiting
Phone: 7877215424
Gildred Colon-Vega, Principal Investigator

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 428000, Russian Federation; Recruiting
Eli Lilly and Company

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., Saratov 410053, Russian Federation; Recruiting
Eli Lilly and Company

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., St. Petersburg 192012, Russian Federation; Recruiting
Eli Lilly and Company

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., Kaohsiung 807, Taiwan; Recruiting
Eli Lilly and Company

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., Sindian City 23148, Taiwan; Recruiting
Eli Lilly and Company

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., Taichung City 40201, Taiwan; Recruiting
Eli Lilly and Company

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., Taichung County 433, Taiwan; Recruiting
Eli Lilly and Company

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., Taichung 40447, Taiwan; Recruiting
Eli Lilly and Company

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 City 10508, Taiwan; Recruiting
Eli Lilly and Company

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 6110, Turkey; Recruiting
Eli Lilly and Company

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., Antalya 07059, Turkey; Recruiting
Eli Lilly and Company

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 27310, Turkey; Recruiting
Eli Lilly and Company

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 34865, Turkey; Recruiting
Eli Lilly and Company

New Horizon Research Center, Miami, Florida 33175, United States; Recruiting
Phone: 305-226-3933
Francisco Miranda, Principal Investigator

Suncoast Clinical Research, New Port Richey, Florida 34652, United States; Recruiting
Phone: 727-849-4131
Lisa Cohen, Principal Investigator

Atlanta Vanguard Medical Associates, Smyrna, Georgia 30082, United States; Recruiting
Phone: 678-305-1700
Faye Vargas-Morris, Principal Investigator

Cotton O'Neil Clinic, Topeka, Kansas 66606, United States; Recruiting
Phone: 785-368-0482
Katherine Willingham, Principal Investigator

Manhattan Medical Research, New York, New York 10016, United States; Recruiting
Phone: 212-480-3333
Susan Zweig, Principal Investigator

Aventiv Research, Columbus, Ohio 43213, United States; Recruiting
Phone: 614-501-6164
Samir Arora, Principal Investigator

University Diabetes and Endocrine Consultants, Chattanooga, Tennessee 37411, United States; Recruiting
Phone: 423-265-3561
David Huffman, Principal Investigator

Dallas Diabetes Endocrine Center, Dallas, Texas 75230, United States; Recruiting
Phone: 972-566-7799
Julio Rosenstock, Principal Investigator

Advanced Research Institute, South Ogden, Utah 84405, United States; Recruiting
Phone: 801-409-2040
Jack Wahlen, Principal Investigator

Tacoma Center for Arthritis Research, PS, Tacoma, Washington 98405, United States; Recruiting
Phone: 253-301-6980
Ronald Graf, Principal Investigator

Starting date: December 2014
Last updated: July 21, 2015