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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 492
- 试验地点
- 16
- 主要终点
- Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).
研究设计
- 研究类型
- Interventional
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 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.
结局指标
主要结局
Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
时间窗: Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
次要结局
- Basal Insulin Dose(Time Frame: Baseline and Week 24)
- Rate of Hypoglycemic Events Adjusted per 30 Days(Time Frame: Baseline through Week 24)
- Percentage of Participants With HbA1c 7% and ≤6.5%(Time Frame: Baseline and Week 24)
- Change from Baseline to 24 Weeks in Body Weight(Time Frame: Baseline, 24 Weeks)
- Insulin Treatment Satisfaction Questionnaire (ITSQ)(Time Frame: Week 4 and Week 24)
- Proportion of Participants with Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®(Time Frame: Baseline through Week 24)
- Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values(Time Frame: Baseline and Week 24)
- Intra-Participant Variability in FBG(Time Frame: Baseline and Week 24)
- Percentage of Participants with Hypoglycemic Events(Time Frame: Baseline through Week 24)
研究者
研究点 (16)
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