NCT05413369已完成3 期
A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 582
- 试验地点
- 60
- 主要终点
- Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis
研究概览
简要总结
This was a parallel-group treatment, Phase 3, randomized, 2-arm study that assessed the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s).
Study details included:
- Study duration per participant: approximately up to 27 weeks
- Treatment duration: 24 weeks
- Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment). There were 14 visits that included 7 phone calls and 7 on-site visits in total during screening and treatment periods. There was a safety follow-up by a phone call visit (End of Study) in 3 days after the last dose of the treatment.
- Health measurement/Observation: change in HbA1c as the primary endpoint.
- Intervention name: iGlarLixi and IDegAsp
- Participant sex: male and female
- Participant age range: adults at least 18 years of age
- Condition/disease: Type 2 diabetes mellitus
详细描述
27 weeks
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
- •Participant had at least 18 of age inclusive, at the time of signing the informed consent.
- •Participants who were diagnosed with T2DM for at least 1 year before the screening visit
- •Participants who were treated for at least 3 months prior to the screening visit with a stable dose of metformin (at least 1000 mg/day or the maximum tolerated dose) alone or in combination with a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl-peptidase-4 (DPP-4) inhibitor or a sodium-glucose co-transporter 2 (SGLT-2) inhibitor
- •HbA1c at screening visit:
- •between 7.5% and 11%, both inclusive, for participants previously treated with metformin alone or + SGLT-2 inhibitor, or
- •between 7.0% and 10%, both inclusive, for participants previously treated with metformin + a second oral antidiabetic treatment other than SGLT-2 inhibitor.
- •Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Body mass index (BMI) <40 kg/m² at screening
- •Male or female, including females of childbearing potential who agreed to use contraception during the study duration
- •Participants were capable of giving signed informed consent as described in Appendix 1 of the protocol which included compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participant who had a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²
- •Pregnant or breast-feeding woman.
- •Woman of childbearing potential not protected by highly effective contraceptive method of birth control and/or who is unwilling or unable to be tested for pregnancy
- •Conditions/situations such as:
- •Participant with short life expectancy.
- •Participant with conditions/concomitant diseases making him/her not evaluable for the primary efficacy endpoint (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to screening).
- •Participant with conditions/concomitant diseases precluding his/her safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period).
- •Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (e.g., participant unable or unwilling to do self-injections or blood glucose monitoring using the Sponsor-provided blood glucometer at home).
- •Previous treatment with insulin (except for short-term treatment ≤14 days due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
- •Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.
- •Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
- •Use of weight loss drugs within 3 months prior to screening.
- •History of discontinuation of a previous treatment with GLP-1 RAs due to safety/tolerability reasons or lack of efficacy.
- •Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.
- •Laboratory findings tested at the screening visit:
- •Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
- •Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).
- •Calcitonin ≥20 pg/mL (5.9 pmol/L).
- •Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm^3 and/or platelets <100 000/mm^
- •Positive urine pregnancy test in female of childbearing potential.
- •Contraindication to metformin and/or SGLT-2 inhibitor use, for those who were taking it prior to the study, according to local labeling, warning/precaution of use (when appropriate) as displayed in the respective National regulation
- •Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- •Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- •Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
- •Any specific situation during study implementation/course that may raise ethics considerations
- •Sensitivity to any of the study interventions (insulin or, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- •Participants who withdrawn consent at randomization or were lost to follow up at randomization visit.
- •The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
iGlarLixi
Experimental
Participants self-administered iGlarLixi (100 units per milliliter [U/mL] insulin glargine + 100 or 50 microgram [mcg]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted.
干预措施: Insulin glargine/Lixisenatide (Drug)
iGlarLixi
Experimental
Participants self-administered iGlarLixi (100 units per milliliter [U/mL] insulin glargine + 100 or 50 microgram [mcg]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted.
干预措施: Metformin (Drug)
iGlarLixi
Experimental
Participants self-administered iGlarLixi (100 units per milliliter [U/mL] insulin glargine + 100 or 50 microgram [mcg]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted.
干预措施: SGLT2 inhibitor (Drug)
IDegAsp
Active Comparator
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
干预措施: IDegAsp (Drug)
IDegAsp
Active Comparator
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
干预措施: Metformin (Drug)
IDegAsp
Active Comparator
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis
时间窗: Baseline, Week 24
Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
次要结局
- Change in HbA1c From Baseline to Week 24: Superiority Analysis(Baseline, Week 24)
- Change in Body Weight From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Reaching HbA1c <7% at Week 24(Week 24)
- Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24(Week 24)
- Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 and no Hypoglycemia During 24-Week Treatment Period(Baseline up to Week 24)
- Change in Fasting Plasma Glucose From Baseline to Week 24(Baseline, Week 24)
- Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Reaching HbA1c <7% at Week 24 With no Hypoglycemia During 24-Week Treatment Period(Baseline up to Week 24)
- Percentage of Participants Reaching HbA1c <7% at Week 24 With no Clinically Relevant Hypoglycemia During 24-Week Treatment Period(Baseline up to Week 24)
- Total Daily Insulin Dose at Week 24(Week 24)
- Percentage of Participants Who Required Rescue Therapy During the 24-Week Treatment Period(Baseline up to Week 24)
- Change in Fasting C-Peptide From Baseline to Week 24(Baseline, Week 24)
- Number of Participants With Any Hypoglycemia Event During On-Treatment Period(From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days))
- Hypoglycemic Event Rate During the On-Treatment Period(From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events Of Special Interest (AESIs) and TEAEs Leading to Treatment Discontinuation(From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days))
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs(From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days))
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology(From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days))
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry(From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days))
研究者
研究点 (60)
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