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
- 已完成
- 入组人数
- 493
- 试验地点
- 13
- 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
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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/m^2).
- •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.
研究组 & 干预措施
LY2963016
Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine hagedorn (NPH) QD will begin the study at their current dose SC. Participants will self titrate LY2963016 based on fasting blood glucose (FBG). Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will continue oral antihyperglycemic medication (OAM).
干预措施: LY2963016 (Drug)
LY2963016
Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine hagedorn (NPH) QD will begin the study at their current dose SC. Participants will self titrate LY2963016 based on fasting blood glucose (FBG). Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will continue oral antihyperglycemic medication (OAM).
干预措施: Oral Antihyperglycemic Medication (Drug)
LANTUS®
Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD will be started at the same dose SC. Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will self titrate LANTUS® based on FBG. Participants will continue OAM.
干预措施: LANTUS® (Drug)
LANTUS®
Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD will be started at the same dose SC. Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will self titrate LANTUS® based on FBG. Participants will continue OAM.
干预措施: Oral Antihyperglycemic Medication (Drug)
结局指标
主要结局
Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 24 weeks
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit\*treatment in the model.
次要结局
- Basal Insulin Dose Units Per Day(Week 24)
- Basal Insulin Dose Per Body Weight (U/kg/Day)(Week 24)
- Percentage of Participants With HbA1c <7% and ≤6.5%(Endpoint [up to 24 weeks])
- Insulin Treatment Satisfaction Questionnaire (ITSQ) Score(Week 4 and Week 24)
- Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®(Endpoint [up to 24 weeks])
- Rate of Hypoglycemic Events Adjusted Per 1 Year(Baseline through Endpoint [up to 24 weeks])
- Percentage of Participants With Hypoglycemic Events(Endpoint [up to 24 weeks])
- Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 24)
- Intra-Participant Variability in Fasting Blood Glucose (FBG)(Week 24)
- Change From Baseline to 24 Weeks in Body Weight(Baseline, 24 Weeks)