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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID: NCT02302716
Run by: Eli Lilly and Company
People needed: 493
Starts: 2014-12-01
Expected to finish: 2016-07-01
Last updated by the study team: 2017-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
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.

Where it is running

New Horizon Research Center — Miami, Florida, United States
Suncoast Clinical Research — New Port Richey, Florida, United States
Atlanta Vanguard Medical Associates — Smyrna, Georgia, United States
Cotton O'Neil Clinic — Topeka, Kansas, United States
Manhattan Medical Research — New York, New York, United States
Aventiv Research — Columbus, Ohio, United States
University Diabetes and Endocrine Consultants — Chattanooga, Tennessee, United States
Dallas Diabetes Endocrine Center — Dallas, Texas, United States
Advanced Research Institute — South Ogden, Utah, United States
Tacoma Center for Arthritis Research, PS — Tacoma, Washington, United States
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
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
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, India
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. — Jaipur, India
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, India
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, India
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, India
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, India
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, India
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, India
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. — Visakhapatnam, India
Manati Center for Clinical Research Inc — Manati, Puerto Rico
American Telemedicine Center — San Juan, Puerto Rico
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
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. — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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