EUCTR2021-003711-25-PL进行中（未招募）1 期
A 24-Week, Single-Arm, Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Switching to iGlarLixi in People with Type 2 Diabetes Mellitus Uncontrolled on Once or Twice Daily Premixed Insulin Regimen - SoliSwitch LPS17008
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Each participant must meet all of the following criteria to be enrolled in this study:
- •1.Is capable of understanding the written informed consent, provides signed written informed consent, is willing and able to complete the electronic diary (eDiary), and agrees to comply with protocol requirements.
- •2.Is an adult =18 years of age.
- •3.Was diagnosed with T2DM at least 6 months before the screening visit.
- •4.Has a body mass index (BMI) =20 and <40 kg/m² during screening.*
- •*Body weight and height will be recorded during screening for the calculation of BMI (metric: BMI = weight (kg)/height [m2]).
- •5.Has an HbA1c =7.5% and =10.0% during screening.
- •6.Has fasting plasma glucose (FPG) values before baseline =130 mg/dL confirmed by the central laboratory at the screening visit.
- •7.Has been on premixed insulin therapy (for =3 months and <10 years of total duration),* with or without OADs that has to be metformin alone or (metformin, plus sodium-glucose co-transporter-2 (SGLT2) inhibitor or DPP-4i, or SU, all of them , with stable doses for 3 months before the screening visit.
- •*Allowed premixed combinations include insulin aspart (30%) + insulin aspart protamine (70%); insulin lispro (25%) + insulin lispro protamine (75%); human insulin isophane suspension (70%) and human insulin injection (recombinant DNA origin, 30%); human insulin isophane
- •suspension (75%) and human insulin injection (recombinant DNA origin,
- •25%) of >12 units/day and <50 units/day.
- •8.If female, is not pregnant or breastfeeding and one of the following conditions applies:
- •8.1) Is a woman of non-childbearing potential (WONCBP), as defined in contraceptive and barrier guidance.
- •8.2) Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1%, as described in contraceptive and barrier guidance during the study treatment period (to be effective before starting the intervention) and for at least 1 week after the last administration of study drug.
- •A WOCBP must have a negative urine pregnancy test at the screening visit.
- •(Note: If a urine test cannot be confirmed as negative [eg, an ambiguous result], a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.)
- •9. For participants on daily DPP-4i, willingness to discontinue DPP-4i before switching to iGlarLixi.
- •10. For participants on SU, willingness to discontinue SU before switching to iGlarLixi.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 146
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 79
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •1.Has been diagnosed with type 1 diabetes mellitus (T1DM).
- •2.Has a history of severe hypoglycemia within 6 months before the screening visit or a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms or as the failure to sense a significant fall in blood glucose below normal levels).
- •3.Has been using OADs other than allowed in the inclusion criterion or metformin plus =2 OADs within the 3 months before the screening visit.
- •4.Has a history of discontinuation of a previous treatment with GLP-1 RA due to safety/tolerability reasons or lack of efficacy.
- •5.Has used weight loss drugs (over-the-counter [OTC] or herbal medications) within 3 months before the screening visit or has a history of bariatric surgery.
- •6.Has any clinically significant abnormality identified on physical examination, vital sign measurements, or laboratory tests (eg, amylase, lipase, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 × upper limit of normal [ULN], calcitonin =20 pg/mL) that, in the opinion of the investigator or any qualified designee, would make
- •implementation of the protocol or interpretation of the study results difficult or would preclude safe participation in the study.
- •7.Is currently hospitalized (except hospitalization for routine diabetes checkup).
- •8.Has a history of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, or pancreatectomy.
- •9.Has severe hypertriglyceridemia (>500 mg/dL).
- •10.Has clinically relevant history of GI disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis or a history of surgery affecting gastric emptying.
- •11.Has a history of metabolic acidosis, including diabetic ketoacidosis, within 1 year before the screening visit.
- •12.Has severe renal impairment or end-stage renal disease, as defined by estimated glomerular filtration rate of <30 mL/min/1.73 m2.
- •13.Has personal or immediate family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes the participant to MTC (eg, multiple endocrine neoplasia syndromes).
- •14.Has received systemic glucocorticoid therapy (excluding topical, intra-articular, or ophthalmic application, nasal spray or inhaled forms) for =10 consecutive days in the last 3 months before the screening visit.
- •15.Has current or known history of alcohol or drug abuse within 6 months before the screening visit.
- •16.Has known presence of factors that interfere with HbA1c measurement (eg, specific hemoglobin variants, hemolytic anemia) that compromises the reliability of HbA1c assessment or has a medical condition that affects interpretation of HbA1c results (eg, blood transfusion or severe blood loss in the last 3 months before the screening visit, any condition that shortens erythrocyte survival).
- •17.Has contraindications to iGlarLixi in accordance with local label or warning/precaution of use (when appropriate), as displayed in the respective National Product Labeling.
- •18.Is subject to any country-related specific regulation that would prevent the participant from entering the study.
- •19.Has been exposed to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, before the screening visit.
研究者
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