A Prospective, Randomized, Open-Label Comparison of aLong-Acting Basal Insulin Analog LY2963016 to Lantus®in Combination with Mealtime Insulin Lispro in AdultPatients with Type 1 Diabetes Mellitus - The ELEMENT 1 Study

Active, not recruiting

• Conditions: type 1 diabetes; MedDRA version: 14.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000829-73-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: 2013-06-17

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

[1] Have T1DM based on the disease diagnostic criteria (World Health
Organization [WHO] Classification)
[2] Aged =18 years
[3] Have duration of diabetes =1 year.
[4] Have HbA1c =11.0 %
[5] On basal-bolus insulin therapy for at least 1 year (basal insulin must be QD injection of NPH, Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart, or glulisine).
[6] Have body mass index (BMI) =35 kg/m2.
[7] As determined by the investigator, are capable and willing to do the
following:
o perform SMBG
o complete patient diaries as required for this protocol
o use the insulin injection device(s) according to the instructions
provided
o are receptive to diabetes education
o comply with the required study insulins and study visits.
[8] 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

[9] Exposure to a biosimilar insulin glargine.
[10] Excessive insulin resistance at entry into the study (total daily insulin dose [TDID] =1.5 U/kg).
[11] Have had more than one episode of severe hypoglycemia, as defined in Section 9.9 of the protocol, within 6 months prior to entry into the study.
[12] Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
[13] Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins.
[14] Are pregnant, 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.
[15] Women who are breastfeeding.
[16] Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
[17] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[18] Have received treatment with pramlintide or with continuous subcutaneous insulin infusion within 3-months prior to Visit 1.
[19] Have congestive heart failure Class III and IV
[20] Have obvious clinical 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.
[21] Have any active cancer, or a personal history of cancer within the previous 5 years (except basal-cell cancer or carcinoma in situ).
[22] Have presence of clinically significant gastrointestinal disease (eg,
gastroparesis).
[23] Have a history of renal transplantation, or are currently receiving renal dialysis, or have creatinine greater than 2.0 mg/dL (177 ?mol/L).
[24] 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.
[25] 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 the 4 weeks immediately preceding Visit 1.
[26] Have an irregular sleep/wake cycle (eg, patients who sleep during the day and work during the night).
[27] Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol.
[28] 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.
[29] Are Lilly employees.
[30] Have previously completed or withdrawn from this study after having signed the ICD.
[31] Are currently enrolled in, or discontinued from 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.

Study & Design

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