Comparison of Lantus to a new basal insulin in patients with diabetes type 2

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2011-000828-15-ES
• Date of registration: 06/07/2011
• Prospective Registration: Yes
• Primary sponsor: Lilly S.A.
• Public title: Comparison of Lantus to a new basal insulin in patients with diabetes type 2
• Scientific title: 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 - ELEMENT 2
• Date of first enrolment: 11/10/2011
• 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: no; 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Operations
• Affiliation: Inmaculada Julian Ortega

• Name: Clinical Operations
• Affiliation: Inmaculada Julian Ortega

Key inclusion & exclusion 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 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 606
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 182

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


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

Health Condition(s) or Problem(s) studied

Type 2 to Diabetes Mellitus
MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

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

Intervention(s)

Product Name: Insulina Glargina Biosimilar
Product Code: LY2963016
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: 160337-95-1
Current Sponsor code: LY2963016
Other descriptive name: N/A
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: LANTUS 100 Unidades/ml solución inyectable en un vial
Product Name: Insulina Glargina
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULINA GLARGINA
CAS Number: 160337-95-1
Other descriptive name: INSULIN GLARGINE
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: not applicable

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: To compare safety of LY2963016 relative to Lantus (eg, incidence of anti-insulin antibodies, hypoglycemia, adverse events [AEs]) when used in combination with OAMs. To compare LY2963016 relative to Lantus for other efficacy variables (eg, change in HbA1c at 4, 8, 12, 16, and 20 weeks, 7-point self-monitored blood glucose profiles [as plasma equivalent values], percentage of patients with HbA1c <7%, percentage of patients with HbA1c ?6.5%). To compare LY2963016 relative to Lantus with regard to intrapatient blood glucose (BG) variability, basal insulin dose, and weight, when used in combination with OAMs. To 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. To compare LY2963016 relative to Lantus for patient-reported outcomes (PRO) as measured by responses to the Adult Low Blood Sugar Survey (ALBSS) and the Insulin Treatment Satisfaction Questionnaire (ITSQ).

Primary end point(s): El criterio principal de valoración de la eficacia es el cambio observado entre la concentración
basal y la concentración final de HbA1c, definida ésta como el valor alcanzado en la 24º semana
(o en la última observación posbasal extrapolada [LOCF])

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: not applicable

Secondary end point(s): not applicable

Secondary ID(s)

I4L-MC-ABEC

2011-000828-15-CZ

Source(s) of Monetary Support

Lilly S.A.

Ethics review

Status: Approved
Approval date: 10/10/2011
Contact:

Results

• Results available: Yes
• Date Posted: 08/07/2018
• Date Completed: 17/09/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-000828-15/results