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

• Register: EUCTR
• Last refreshed on: 16 October 2012
• Main ID: EUCTR2011-000828-15-IT
• Date of registration: 24/01/2012
• Prospective Registration: No
• Primary sponsor: ELI LILLY
• Public title: 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
• Scientific title: 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 - The Element 2 study
• Date of first enrolment: 29/08/2011
• Target sample size: 792
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000828-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Czech Republic, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Eli Lilly

• Name: Clinical Trial Information Desk
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

type 2 diabetes mellitus
MedDRA version: 14.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: biosimilar insuline glargine
Product Code: LY2963016
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337951
Current Sponsor code: LY2963016
Other descriptive name: biosimilar insulin glargine
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: LANTUS*SC 10FL 100UI/ML 5ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337951
Other descriptive name: insulin glargine
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): The primary objective of this study is to test the hypothesis that LY2963016 administered once daily (QD) is noninferior to Lantus administered QD, as measured by change in hemoglobin A1c (HbA1c) from baseline to 24 weeks, when used in combination with OAMs.

Main Objective: The primary objective of this study is to test the hypothesis that LY2963016 administered once daily (QD) is noninferior to Lantus administered QD, as measured by change in hemoglobin A1c (HbA1c) from baseline to 24 weeks, when used in combination with OAMs

Secondary Objective: compare safety of LY2963016 relative to Lantus (eg, incidence of anti-insulin antibodies, hypoglycemia, adverse events [AEs]) when used in combination with OAMs. compare LY2963016 relative to Lantus for other efficacy variables (eg, change in HbA1c at 4, 8, 12, 16, and 20 weeks, 7-point selfmonitored blood glucose profiles [as plasma equivalent values], percentage of patients with HbA1c <7%, percentage of patients with HbA1c =6.5%). compare LY2963016 relative to Lantus with regard to intrapatient blood glucose (BG) variability, basal insulin dose, and weight, when used in combination with OAMs. test the hypothesis that Lantus is noninferior to LY2963016 (QD), as measured by change in HbA1c from baseline to 24 weeks, when used in combination with OAMs. compare LY2963016 relative to Lantus for patient-reported outcomes as measured by responses to the ALBSS and the ITSQ

Timepoint(s) of evaluation of this end point: 24-week treatment and 4- week post-treatment follow-up study in adult patients with type 2 diabetes mellitus (T2DM).

Secondary Outcome(s)

Secondary end point(s): compare safety of LY2963016 relative to Lantus (eg, incidence of anti-insulin antibodies, hypoglycemia, adverse events [AEs]) when used in combination with OAMs. compare LY2963016 relative to Lantus for other efficacy variables (eg, change in HbA1c at 4, 8, 12, 16, and 20 weeks, 7-point selfmonitored blood glucose profiles [as plasma equivalent values], percentage of patients with HbA1c <7%, percentage of patients with HbA1c =6.5%). compare LY2963016 relative to Lantus with regard to intrapatient blood glucose (BG) variability, basal insulin dose, and weight, when used in combination with OAMs. test the hypothesis that Lantus is noninferior to LY2963016 (QD), as measured by change in HbA1c from baseline to 24 weeks, when used in combination with OAMs. compare LY2963016 relative to Lantus for patient-reported outcomes as measured by responses to the ALBSS and the ITSQ

Timepoint(s) of evaluation of this end point: 24-week treatment and 4- week post-treatment follow-up study in adult patients with type 2 diabetes mellitus (T2DM).

Secondary ID(s)

2011-000828-15-CZ

I4L-MC-ABEC

Source(s) of Monetary Support

Eli Lilly and Company