CTRI/2023/12/060953尚未招募4 期
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 - NI
Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Subjects diagnosed (clinically) with T2DM for =1 year prior to screening.
- •2. 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
- •3. 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
- •4. Have an HbA1c value =7.5% and =10% according to the central laboratory at screening
- •5. Body mass index =45.0 kg/m2
排除标准
- •1. 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
- •2. Have been diagnosed, at any time, with T1DM or latent autoimmune diabetes in adults
- •3. Have hypoglycemia unawareness as judged by the investigator
- •4. Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening
- •5. Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening
- •6. Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)
- •7. Excessive insulin resistance defined as having received a total daily dose of insulin >2.0 U/kg at the time of screening
- •8. Have a history of or are being evaluated for bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve
- •9. 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
- •10. Renal:
- •a. History of renal transplantation
- •b. Currently receiving renal dialysis
- •c. Serum creatinine >2.0 mg/dL (177 µmol/L) at screening
- •11. 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.
- •12. 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
- •13. Having any hypersensitivity or allergy to any of the insulins or excipients used in this trial
- •14. 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
- •15. Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator’s opinion
研究者
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