Protocol I4L-MC-ABEC(a) A ProspEctive, Randomized, DoubLE-Blind CoMparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult PatiENTs with Type 2 Diabetes Mellitus: The ELEMENT 2 Study

• Conditions: type 2 diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000828-15-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-24
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

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

Inclusion Criteria

[1] Have T2DM based on 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. [4] Have an HbA1c =7.0% and =11.0% if insulin naïve; if previously on Lantus, then HbA1c =11.0%. [5] (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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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 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 [ALT]; or [AST] greater than 2.5 times the upper limit of the reference range; or albumin value above or below the normal reference range [18] Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease [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 [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