A Prospective, Randomized, Double-Blind Comparisonof a Long-Acting Basal Insulin Analog LY2963016 toLantus® in Adult Patients with Type 2 Diabetes Mellitus - The ELEMENT 2 Study

• Conditions: type 2 diabetes mellitus; MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000828-15-GR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-19
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 792

Inclusion Criteria

[1] Have T2DM based on the disease diagnostic criteria World Health
Organization (WHO) classification.
[2] Are =18 years of age.
[3] Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to Visit 1, with or without Lantus. Note: use and dose of oral agents in combination with insulin must be in accordance with the local product label.
Patients taking metformin and who are found to have a contraindicated serum creatinine level (=1.4 mg/dL for females, =1.5 mg/dL for males, or based on country-specific label) must be willing to discontinue use of metformin at randomization.
If on two OAMs at study entry and there is a need to discontinue one of those agents due to country labeling requirements or clinical parameters, that patient would not meet entry criteria.
[4] Have an HbA1c =7.0% and =11.0% if insulin naïve; if previously on Lantus, then HbA1c =11.0%.
[5] Body mass index (BMI) =45 kg/m2.
[6] As determined by the investigator, are capable and willing to do the
following:
? perform SMBG
? complete patient diaries as required
? use covered insulin vial and syringe according to study instructions
? are receptive to diabetes education
? comply with required study treatment and study visits.
[7] Have given written informed consent to participate in this study in accordance with local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[8] Have used any other insulin except Lantus, including commercial and investigational insulins within the previous 30 days.
[9] Have been exposed to a biosimilar insulin glargine within the previous 90 days.
[10] Have a history of taking basal bolus therapy or who, in the investigator's opinion, require mealtime insulin in order to achieve target control.
[11] Have used short-acting glucagon like peptide (GLP-1) agonist (eg, exenatide) or long-acting GLP-1 agonist (eg, liraglutide) within the previous 90 days.
[12] Have used pramlintide (eg, Symlin®) within the previous 30 days.
[13] Have excessive insulin resistance at study entry (total insulin dose =1.5 U/kg).
[14] Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
[15] Have known hypersensitivity or allergy to Lantus or its excipients.
[16] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within 4 weeks immediately preceding Visit 1.
[17] Have obvious signs or symptoms, or laboratory evidence, of liver disease (alanine aminotransferase [ALT]; or aspartate minotransferase [AST] greater than 2.5 times the upper limit of the reference range, as defined by the central laboratory); or albumin value above or below the normal reference range, as defined by the central laboratory.
[18] Have one of the following concomitant diseases: significant cardiac (eg, congestive heart failure Class III or IV) or gastrointestinal disease (eg, significant gastroparesis).
[19] Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 mg/dL
[20] Have had a blood transfusion or severe blood loss within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
[21] Patients with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ).
[22] Are investigator-site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[23] Have any other condition (including known drug or alcohol abuse or
psychiatric disorder) that precludes the patient from following and completing
the protocol.
[24] Are Lilly employees.
[25] 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.
[26] Have previously completed or withdrawn from this study.
[27] Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
[28] Women who are breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified