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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02302716 |
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Date of registration:
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25/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus
ELEMENT 5 |
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Scientific title:
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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 |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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493 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02302716 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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India
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Korea, Republic of
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Puerto Rico
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Russian Federation
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Taiwan
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Turkey
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United States
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: LANTUS®
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Drug: LY2963016
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Drug: Oral Antihyperglycemic Medication
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Primary Outcome(s)
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Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
[Time Frame: Baseline, 24 weeks]
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Secondary Outcome(s)
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Percentage of Participants With Hypoglycemic Events
[Time Frame: Endpoint [up to 24 weeks]]
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Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®
[Time Frame: Endpoint [up to 24 weeks]]
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Basal Insulin Dose Units Per Day
[Time Frame: Week 24]
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Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
[Time Frame: Baseline, Week 24]
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Basal Insulin Dose Per Body Weight (U/kg/Day)
[Time Frame: Week 24]
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Rate of Hypoglycemic Events Adjusted Per 1 Year
[Time Frame: Baseline through Endpoint [up to 24 weeks]]
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Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
[Time Frame: Week 4 and Week 24]
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Percentage of Participants With HbA1c <7% and =6.5%
[Time Frame: Endpoint [up to 24 weeks]]
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Change From Baseline to 24 Weeks in Body Weight
[Time Frame: Baseline, 24 Weeks]
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Intra-Participant Variability in Fasting Blood Glucose (FBG)
[Time Frame: Week 24]
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Secondary ID(s)
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I4L-MC-ABER
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15615
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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