EUCTR2011-000829-73-DE进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[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 for at least 3 months (90 days) prior to Visit 1 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 instructed for this protocol
- •o use the insulin injection device(s) according to the instructions
- •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
排除标准
- •[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 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.
- •[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, clinically active gastroparesis associated with wide glucose fluctuations).
- •[23] Have a history of renal transplantation, or are currently receiving renal dialysis, or have creatinine greater than 2.0 mg/dL (177 µmol/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 at pharmacological doses (excluding topical, intraarticular, intraocular, or inhaled preparations, and physiologic replacement doses for Addison’s disease or adrenal deficiency) 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 concurrent
研究者
相似试验
进行中（未招募）
不适用
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 StudyMedDRA version: 14.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorderstype 1 diabetesEUCTR2011-000829-73-GREli Lilly and Company550
进行中（未招募）
不适用
ot availabletype 1 diabetesEUCTR2011-000829-73-HUEli Lilly and Company550
进行中（未招募）
3 期
A study to compare long acting basal insulin analog to lantus in adult patients with Type 2 Diabetes MellitusCTRI/2015/02/005536Eli Lilly and Company492
进行中（未招募）
不适用
ot availableMedDRA version: 14.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorderstype 1 diabetesEUCTR2011-000829-73-BEEli Lilly and Company550
未知
3 期
A Study in Adults With Type 1 DiabetesDiabetes Mellitus, Type 1JPRN-jRCT2080221613Eli Lilly Japan K.K.