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Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (GetGoal-M-Asia)

2016년 8월 18일 업데이트: Sanofi

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over a period of 24 weeks of treatment.

The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010) in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) and glucose excursion during standardized meal test, body weight; to evaluate safety, tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The study duration for each patient is 27 weeks +/- 10 days (up to 2 weeks screening + 1 week run-in + 24 weeks double-blind treatment + 3 days follow-up).

연구 유형

중재적

등록 (실제)

391

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 말레이시아
      • Kelantan, 말레이시아, 16150
        • Investigational Site Number 458001
      • Kuala Lumpur, 말레이시아, 59100
        • Investigational Site Number 458003
      • Putrajaya, 말레이시아, 62250
        • Investigational Site Number 458002
  • 중국
      • Beijing, 중국, 100034
        • Investigational Site Number 156011
      • Beijing, 중국, 100101
        • Investigational Site Number 156012
      • Beijing, 중국, 100191
        • Investigational Site Number 156019
      • Beijing, 중국, 100700
        • Investigational Site Number 156002
      • Beijing, 중국, 100730
        • Investigational Site Number 156003
      • Beijing, 중국, 100730
        • Investigational Site Number 156009
      • Beijing, 중국, 100853
        • Investigational Site Number 156001
      • Changchun, 중국, 130041
        • Investigational Site Number 156036
      • Changsha, 중국, 410008
        • Investigational Site Number 156016
      • Changsha, 중국, 410011
        • Investigational Site Number 156015
      • Chengdu, 중국, 610041
        • Investigational Site Number 156006
      • Chengdu, 중국, 610072
        • Investigational Site Number 156032
      • Dalian, 중국, 116027
        • Investigational Site Number 156010
      • Guangzhou, 중국, 510080
        • Investigational Site Number 156004
      • Guangzhou, 중국, 510080
        • Investigational Site Number 156008
      • Guangzhou, 중국, 510630
        • Investigational Site Number 156025
      • Haikou, 중국, 57028
        • Investigational Site Number 156031
      • Harbin, 중국, 150001
        • Investigational Site Number 156014
      • Hefei, 중국, 230022
        • Investigational Site Number 156029
      • Qingdao, 중국, 266003
        • Investigational Site Number 156013
      • Shanghai, 중국, 200003
        • Investigational Site Number 156007
      • Shanghai, 중국, 200065
        • Investigational Site Number 156030
      • Shenyang, 중국, 110004
        • Investigational Site Number 156020
      • Suzhou, 중국, 215004
        • Investigational Site Number 156035
      • Taiyuan, 중국, 030001
        • Investigational Site Number 156033
      • Tianjin, 중국, 300052
        • Investigational Site Number 156037
      • Xi'An, 중국, 710032
        • Investigational Site Number 156022
      • Xi'An, 중국, 710061
        • Investigational Site Number 156023
  • 태국
      • Bangkok, 태국, 10400
        • Investigational Site Number 764002
  • 홍콩
      • Hong Kong, 홍콩
        • Investigational Site Number 344001
      • Hong Kong, 홍콩
        • Investigational Site Number 344003
      • Shatin, Nt, 홍콩
        • Investigational Site Number 344002

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion criteria:

- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with metformin alone or metformin with sulfonylurea at the time of the screening visit

Exclusion criteria:

  • HbA1c <7% or greater than (>) 10% at screening
  • At the time of screening age < legal age of majority
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • Type 1 diabetes mellitus
  • Treatment with metformin not at a stable dose of at least 1.0 gram per day or more than 1.5 gram per day for at least 3 months prior to screening visit
  • In case of treatment with sulfonylurea, if the sulfonylurea dosage is less than the maximum effective dose (that is, half of the maximum recommended dose according to local labeling), or is not at a stable (unchanged) dose for at least 3 months prior to screening
  • FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L])
  • History of hypoglycemia unawareness
  • Body mass index <=20 kilogram per square meter (kg/m^2)
  • Weight change of >5 kg during the 3 months preceding the screening visit
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease or patients considered by the investigator at high risk for acute pancreatitis (for example, with known history of biliary gallstone[s], or with very high triglyceride level [>=5.65 mmol/L]) at the time of screening
  • Personal or family history of medullary thyroid cancer or genetic conditions that predispose to medullary thyroid cancer (for example, multiple endocrine neoplasia syndromes);
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
  • Known history of drug or alcohol abuse within 6 months prior to the time of screening
  • Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure (SBP) or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively
  • Laboratory findings at the time of screening: amylase and/or lipase: >3 times upper limit of normal (ULN); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; calcitonin >20 picogram per milliliter (5.9 picomole per liter) ; and positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
  • Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram, or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment
  • Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as attending scheduled visits, being able to do self-injections; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)
  • Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin and sulfonylurea (for example, alpha-glucosidase inhibitor, thiazolidinedione, glucagon-like peptide -1 [GLP-1], receptor agonist, dipeptidyl-peptidase-4 inhibitors, insulin) within 3 months prior to the time of screening
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
  • Use of any investigational drug within 3 months prior to screening;
  • Participation in a previous study with lixisenatide
  • Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
  • Allergic reaction to any GLP-1 agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Lixisenatide
1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 2 weeks, followed by 20 mcg QD up to Week 24.
의약품: 릭시세나타이드(AVE0010)
아침 식사 전 1시간 이내에 1일 1회 피하 주사로 자가 투여합니다.
장치: 펜 자동 주사기
다른 이름들:
  • OptiClik®
의약품: Metformin
Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24.
의약품: Sulfonylurea
Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c <8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c >=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.
위약 비교기: Placebo
1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, followed by 20 mcg QD up to Week 24.
장치: 펜 자동 주사기
다른 이름들:
  • OptiClik®
의약품: Metformin
Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24.
의약품: Sulfonylurea
Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c <8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c >=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.
의약품: 위약
아침 식사 전 1시간 이내에 1일 1회 피하 주사로 자가 투여합니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
기간: Baseline, Week 24
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Baseline, Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
기간: Baseline, Week 24
Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
기간: Baseline, Week 24
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.
Baseline, Week 24
Change From Baseline in Body Weight at Week 24
기간: Baseline, Week 24
Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24
기간: Week 24
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Week 24
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
기간: Week 24
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Week 24
Change From Baseline in Glucose Excursion at Week 24
기간: Baseline, Week 24
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.
Baseline, Week 24
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period
기간: Baseline up to Week 24
Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Baseline up to Week 24

기타 결과 측정

결과 측정
측정값 설명
기간
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24
기간: Baseline, Week 24
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
증상성 저혈당증 및 중증 증상성 저혈당증 환자 수
기간: 마지막 용량 투여 후 최대 3일까지 연구 약물의 첫 번째 용량
증상성 저혈당증은 60mg/dL(3.3mmol/L) 미만의 혈장 포도당을 수반하는 저혈당 에피소드의 결과로 간주되거나 경구 탄수화물, 정맥 포도당 또는 글루카곤 투여 후 즉각적인 회복과 관련된 임상 증상이 있는 사건입니다. 혈장 포도당 측정이 가능하지 않은 경우. 중증 증상성 저혈당증은 환자가 다른 사람의 도움을 필요로 하고 혈장 포도당 수치가 36mg/dL(2.0mmol/L) 미만이거나 경구 탄수화물, 정맥 포도당 또는 글루카곤 투여 후 즉각적인 회복과 관련된 증상성 저혈당증 사건이었습니다. , 혈장 포도당 측정이 가능하지 않은 경우.
마지막 용량 투여 후 최대 3일까지 연구 약물의 첫 번째 용량

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sanofi

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 7월 1일

기본 완료 (실제)

2011년 12월 1일

연구 완료 (실제)

2011년 12월 1일

연구 등록 날짜

최초 제출

2010년 7월 23일

QC 기준을 충족하는 최초 제출

2010년 7월 23일

처음 게시됨 (추정)

2010년 7월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 10월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 8월 18일

마지막으로 확인됨

2016년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • EFC11321
  • U1111-1116-8938 (기타 식별자: UTN)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제2형 당뇨병에 대한 임상 시험

릭시세나타이드(AVE0010)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Argentina

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다