NCT06370715已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Percentage of Participants with at least 1 Episode of Hypoglycemia
研究概览
简要总结
The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.
The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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) for ≥1 year prior to screening
- •Treated for ≥90 days prior to screening with multiple daily injection (MDI) therapy
- •on basal insulin or insulin glargine 100 U/mL [Basaglar or Lantus] or insulin glargin 300 U/mL, insulin determir, insulin degludec U-100, or neutral protamine Hagedorn (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, fast-acting insulin aspart), or
- •premixed analog or human insulin regimens with any basal and bolus insulin
- •May have been treated with up to 3 oral antihyperglycemic medications (OAMs) including metformin, sodium-glucose cotransporter (SGLT)-2 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
- •Have access to a telephone, or alternative means for close monitoring/communications
- •Have refrigeration at home or have ready access to refrigeration for storage of insulin therapy
- •Have a regular wake-sleep schedule (awake-work during the day and sleep during the night)
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 type 1 diabetes mellitus (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
- •Currently receiving renal dialysis
- •Serum creatinine >2.0 mg/dL (177 µmol/L) at screening
- •Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements
- •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
- •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 HbA1
- •Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator's opinion
- •Have used thiazolidinediones, glucagon-like peptide 1 receptor agonist, or pramlintide within 90 days prior to screening
研究组 & 干预措施
Insulin Lispro-aabc + Insulin Glargine
Experimental
Participants will receive insulin lispro-aabc in combination with insulin glargine administered by subcutaneous (SC) injection.
干预措施: Insulin Lispro-aabc (Drug)
Insulin Lispro-aabc + Insulin Glargine
Experimental
Participants will receive insulin lispro-aabc in combination with insulin glargine administered by subcutaneous (SC) injection.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Percentage of Participants with at least 1 Episode of Hypoglycemia
时间窗: Baseline through Week 26
Percentage of participants with at least 1 episode of hypoglycemia will be reported.
次要结局
- Change from Baseline to Week 26 in Body Weight(Baseline, Week 26)
- Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 26)
- Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c)(Baseline, Week 26)
- Percentage of Participants Achieving HbA1c Less Than (<) 7%(Week 26)
- Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values(Baseline, Week 26)
- Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score(Baseline, Week 26)
- Change from Baseline to Week 26 in Bolus Insulin Dose(Baseline, Week 26)
- Change from Baseline to Week 26 in Bolus Basal: Bolus Ratio(Baseline, Week 26)
- Change from Baseline to Week 26 in Basal Insulin Dose(Baseline, Week 26)
- Percentage of Participants with Severe Hypoglycemic Events(Week 26)
- Percentage of Participants with Nocturnal Hypoglycemia Events(Week 26)
- Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events(Week 26)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 DiabetesDiabetes Type 1NCT03433677Eli Lilly and Company49
已完成
1 期
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 DiabetesType 1 DiabetesNCT03903016Sanofi90
已完成
3 期
Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus PatientsDiabetes MellitusDiabetes Mellitus, Type 2NCT04023344Geropharm210
已完成
3 期
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes MellitusDiabetes MellitusNCT00467376Sanofi485
已完成
4 期
Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without InsulinType 2 Diabetes MellitusNCT00036504Eli Lilly and Company100