EUCTR2011-000829-73-GR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 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
- •o perform SMBG
- •o complete patient diaries as required 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, 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.
研究者
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