CTRI/2015/02/005536进行中（未招募）3 期
A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to LANTUS® in Adult Patients with Type 2 Diabetes Mellitus: the ELEMENT 5 Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 492
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Have type 2 diabetes mellitus (T2DM).
- •-Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening, with or without basal insulin.
- •-If currently on basal insulin, must be taking LANTUS® QD or NPH or insulin detemir either QD or twice a day for at least 90 days prior to study entry.
- •-Have an HbA1c >=7.0% and <=11.0% if insulin naïve; if previously on basal insulin, then HbA1c <=11.0%.
- •-Body mass index (BMI) <=45 kilograms per meter squared (kg/m2).
- •-As determined by the investigator, are capable and willing to do the following:
- •Perform self monitored blood glucose (SMBG)
- •Complete participant diaries as instructed
- •Are receptive to diabetes education
- •Comply with required study treatment and study visits
排除标准
- •-Have been on LANTUS® more than once daily within the previous 30 days.
- •-Have used any other insulin except the entry insulin [LANTUS®, insulin detemir, or NPH] including commercial (includes any premixed insulins) and investigational insulins within the previous 30 days.
- •-Have been exposed to a biosimilar insulin glargine within the previous 90 days.
- •-Have participated in a LY2963016 study.
- •-Have taken basal plus mealtime insulin (basal bolus therapy) within the last year for greater than 4 continuous weeks.
- •-Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
- •-Have used pramlintide within the previous 30 days.
- •-Have excessive insulin resistance at study entry (total insulin dose >=1.5 units/kg).
- •-Have more than 1 episode of severe hypoglycemia within 6 months prior to screening.
- •-Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
- •-Have known hypersensitivity or allergy to LANTUS® or its excipients.
- •-Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy or have received such therapy within 4 weeks immediately preceding screening.
- •-Have obvious signs or symptoms, or laboratory evidence, of liver disease.
- •-Have one of the following concomitant diseases: significant cardiac (e.g., congestive heart failure Class III or IV) or gastrointestinal disease (e.g., significant gastroparesis).
- •-Have a history of renal transplantation or are currently receiving renal dialysis.
- •-Have a serum creatinine greater than 2.0 milligrams/deciliter (177 micromoles/liter).
- •-Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
- •-Participants with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ).
- •-Have a history or diagnosis of Human Immunodeficiency Virus (HIV) infection.
- •-Have any other condition (including known drug or alcohol abuse or psychiatric disorder including dementia) that precludes the participant from following and completing the protocol.
- •-Are pregnant or intend to become pregnant during the course of the study.
- •-Women who are breastfeeding.
- •-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.
研究者
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未知
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