Diabetes Mellitus, Type 2Phase 3ELEMENT 5NCT02302716
A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus
A Phase 3 study testing LY2963016, LANTUS® and Oral Antihyperglycemic Medication in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 44 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY2963016, LANTUS® and Oral Antihyperglycemic Medication
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 44 sitesin 7 countries
- Study dates
- Dec 2014to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- perform self monitored blood glucose (SMBG)
- complete participant diaries as instructed
- are receptive to diabetes education
- comply with required study treatment and study visits
Who cannot join
- 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.
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- 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.
Trial locations and contacts
44 sites in 7 countries.
44 sites in 7 countries
India11 sites
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
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Chennai, 600086
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Hyderabad, 500 012
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Jaipur, 302020
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Kormangala, 560034
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Mumbai, 40016
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New Delhi, 110060
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Panjim, 403001
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Pune, 411001
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Secunderabad, 500033
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Visakhapatnam, 530002
United States10 sites
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411
Aventiv Research
Columbus, Ohio, 43213
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
New Horizon Research Center
Miami, Florida, 33175
Suncoast Clinical Research
New Port Richey, Florida, 34652
Manhattan Medical Research
New York, New York, 10016
Atlanta Vanguard Medical Associates
Smyrna, Georgia, 30082
Advanced Research Institute
South Ogden, Utah, 84405
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, 98405
Cotton O'Neil Clinic
Topeka, Kansas, 66606
South Korea9 sites
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Ansan-si, 425-707
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Bucheon-si, 420-717
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Daegu, 700-712
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Goyang, 411-706
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Goyang-si, 410-719
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Jeju City, 690-767
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Pusan, 602-739
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Seoul, 139-872
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Suwon, 442-723
Taiwan5 sites
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Sindian City, 23148
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Taichung, 40201
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Taichung, 40447
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Taichung, 433
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Taipei, 10508
Turkey (Türkiye)4 sites
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Ankara, 6110
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Antalya, 07059
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Gaziantep, 27310
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Istanbul, 34865
Russia3 sites
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
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, 192012
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
Puerto Rico2 sites
Manati Center for Clinical Research Inc
Manati, 00674
American Telemedicine Center
San Juan, 00917
About this study
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
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).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2963016, LANTUS®, Oral Antihyperglycemic Medication
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2963016Drug
Administered SC
LANTUS®Drug
Administered SC
Oral Antihyperglycemic MedicationDrug
Administered as per standard-of-care.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: LY2963016; Drug: 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. Receives: Drug: LANTUS®; Drug: Oral Antihyperglycemic Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 24 weeks
Secondary outcomes (10)
Percentage of Participants With HbA1c <7% and ≤6.5%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Measured: Endpoint [up to 24 weeks]
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.
Measured: Baseline, Week 24
Intra-Participant Variability in Fasting Blood Glucose (FBG)
Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Intra-Participant FBG variability was calculated based on the standard deviation (SD) of the morning pre-meal BG value. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.
Measured: Week 24
Basal Insulin Dose Units Per Day
Units of Basal Insulin dose taken per day (U/day). Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.
Measured: Week 24
Basal Insulin Dose Per Body Weight (U/kg/Day)
Basal Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.
Measured: Week 24
Change From Baseline to 24 Weeks in Body Weight
Change from baseline in body weight. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.
Measured: Baseline, 24 Weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. LS means was determined by MMRM with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.
Measured: Week 4 and Week 24
Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®
The percentage of participants with detected insulin antibodies were summarized as counts and percentages at baseline, at each visit, at the 24-week endpoint (LOCF), and overall for the 24-week treatment period.
Measured: Endpoint [up to 24 weeks]
Rate of Hypoglycemic Events Adjusted Per 1 Year
The rate of hypoglycemic events were analyzed at baseline, titration, maintenance, and overall study periods and at endpoint using the Wilcoxon test. In addition, a negative binomial model was used as a sensitivity analysis. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.
Measured: Baseline through Endpoint [up to 24 weeks]
Percentage of Participants With Hypoglycemic Events
The percentage of participants (with at least 1 hypoglycemic event (total, severe, nocturnal, and others) or incidence during the study was analyzed using Fisher's exact test. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.
Measured: Endpoint [up to 24 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- 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, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302716
- Sponsor's protocol ID
- 15615
- Other IDs
- I4L-MC-ABER
- Acronym
- ELEMENT 5
- Status last verified
- Sep 2017
- First submitted
- 25 Nov 2014
- Last updated
- 24 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Publications
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.
PubMed 31119716Pollom 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.
PubMed 30604091
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02302716
- Acronym / sponsor ID
- ELEMENT 5 / 15615
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Posted 24 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2963016 | Experimental | Drug: LY2963016, Drug: Oral Antihyperglycemic MedicationInsulin 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). |
| LANTUS® | Active comparator | Drug: LANTUS®, Drug: Oral Antihyperglycemic MedicationInsulin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2963016Administered SC | Drug | LY2963016 |
| LANTUS®Administered SC | Drug | LANTUS® |
| Oral Antihyperglycemic MedicationAdministered as per standard-of-care. | Drug | LANTUS®, LY2963016 |
Primary outcome
Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 24 weeks
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.
10 secondary outcomes
Percentage of Participants With HbA1c <7% and ≤6.5%
Time frame: Endpoint [up to 24 weeks]
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Time frame: Baseline, Week 24
Intra-Participant Variability in Fasting Blood Glucose (FBG)
Time frame: Week 24
Basal Insulin Dose Units Per Day
Time frame: Week 24
Basal Insulin Dose Per Body Weight (U/kg/Day)
Time frame: Week 24
Change From Baseline to 24 Weeks in Body Weight
Time frame: Baseline, 24 Weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
Time frame: Week 4 and Week 24
Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®
Time frame: Endpoint [up to 24 weeks]
Rate of Hypoglycemic Events Adjusted Per 1 Year
Time frame: Baseline through Endpoint [up to 24 weeks]
Percentage of Participants With Hypoglycemic Events
Time frame: Endpoint [up to 24 weeks]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31119716Mohan 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.
- Derived from this study: PubMed 30604091Pollom 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.
- Individual participant dataSharing planned: Yes. Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Eli Lilly and Company
44 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2963016, LANTUS® and Oral Antihyperglycemic Medication in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 44 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in India, United States, South Korea, Taiwan, Turkey (Türkiye) and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.