CTRI/2023/12/060953招募中Unknown
A 26-Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess the Safety of Lyumjev in Adult Patients with Type 2 Diabetes Mellitus in India
Eli Lilly and Company India Pvt Ltd13 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年4月15日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- Incidence (percentage of subjects with at least 1 event) and rate (events/subject/year) of all documented hypoglycemia (BG<54 mg/dL)
研究概览
简要总结
Lyumjev® received marketing approval in India on 06 July 2021 for the treatment of adults with type 2 diabetes mellitus (T2DM) 18 years or older.
The aim of this study is to evaluate the safety of Lyumjev, as measured by incidence and rate of documented hypoglycemia from baseline to Week 26 in subjects with T2DM, when administered as a multiple daily injection (MDI) regimen in combination with basal insulin glargine 100 U/mL pen (Basaglar®).
Results of this study will satisfy the request from Drug Controller General of India to provide safety and efficacy data in a minimum of 100 additional Indian subjects.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed (clinically) with T2DM for ≥1 year prior to screening.
- •Treated for ≥90 days prior to screening with MDI therapy a.
- •On basal insulin (insulin glargine 100 U/mL [Basaglar or Lantus] or insulin glargine 300 U/mL, insulin detemir, insulin degludec U-100, or NPH insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro 100 U/mL or 200 U/mL, insulin aspart, insulin glulisine, regular insulin, Fiasp® fast-acting insulin aspart), OR b.
- •premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily except for IDegAsp injected once daily
- •May have been treated with up to 3 OAMs including metformin, sodium-glucose cotransporter (SGLT)-2 inhibitor, dipeptidyl peptidase (DPP)-4 inhibitor, sulfonylurea, meglitinide, or alpha glucosidase inhibitor in accordance with local regulations.
- •The dose of all OAMs must have been stable for ≥90 days prior to screening
- •Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening
- •Body mass index ≤45.0 kg/m2.
排除标准
- •Having any other condition (including known drug or alcohol abuse, psychiatric disorder including eating disorder) that precludes the subject from following and completing the protocol
- •Have been diagnosed, at any time, with T1DM or latent autoimmune diabetes in adults
- •Have hypoglycemia unawareness as judged by the investigator
- •Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening
- •Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening
- •Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)
- •Excessive insulin resistance defined as having received a total daily dose of insulin >2.0 U/kg at the time of screening
- •Have a history of or are being evaluated for bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve
- •Have cardiovascular disease, within the past 6 months prior to screening, defined as stroke, decompensated heart failure (New York Heart Association Class III or IV), myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft
- •History of renal transplantation b.
- •Currently receiving renal dialysis c.
- •Serum creatinine >2.0 mg/dL (177 μmol/L) at screening
- •Hepatic: Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements as indicated below at screening: a.
- •Total bilirubin level (TBL) ≥2X the upper limit of normal (ULN [with the exception of Gilbert’s disease]) as defined by the central laboratory, or b.
- •Alanine aminotransferase (ALT) ≥3X ULN as defined by the central laboratory, or c.
- •Aspartate aminotransferase (AST) ≥3X ULN as defined by the central laboratory.
- •Malignancy: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- •Having any hypersensitivity or allergy to any of the insulins or excipients used in this trial
- •Hematologic: Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia, or any other traits known to interfere with measurement of HbA1c
- •Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator’s opinion.
结局指标
主要结局
Incidence (percentage of subjects with at least 1 event) and rate (events/subject/year) of all documented hypoglycemia (BG<54 mg/dL)
时间窗: From baseline through Week 26
次要结局
- 1. SAEs and TEAEs(2. Incidence and rate (events/subject/year) of severe hypoglycemic events)
研究者
研究点 (13)
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