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

Eli Lilly and Company0 sites792 target enrollmentSeptember 9, 2011

Conditionstype 2 diabetes mellitus MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsLantus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: type 2 diabetes mellitus
Sponsor: Eli Lilly and Company
Enrollment: 792
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 9, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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 \[123\.8 µmol/L] for females, \=1\.5 mg/dL \[132\.6 µmol/L] for males, or based on country\-specific label) must be willing to discontinue use of metformin at randomization.
•Note: Sitagliptin is the only DPP\-IV inhibitor currently approved for use with insulin.
•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 instructed

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 at pharmacological doses (excluding topical, intraarticular, intraocular, or inhaled preparations and physiologic replacement doses for adrenal deficiency) 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 aminotransferase \[AST] greater than 2\.5 times the upper limit of the reference range, as defined by the central laboratory; or albumin value remarkably above or below the normal reference range, as defined by the central laboratory).