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24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine (GetGoal-Duo1)

2016年8月18日 更新者：Sanofi

A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

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

The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The study comprises 3 periods:

  • An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs.
  • At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or equal to (>=) 7% and less than or equal to (<=) 9% and whose mean fasting self-monitored plasma glucose (SMPG) calculated from the self measurements for the 7 days prior to Visit 12 (Week -1) is <=140 milligram per deciliter (mg/dL) (7.8 millimole per liter [mmol/L]), would enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/- TZDs).
  • A 3-day safety follow up period.

Maximum duration is of 39 weeks +/- 7 days.

研究类型

介入性

注册 (实际的)

446

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Frederiksberg、丹麦、2000
        • Sanofi-Aventis Investigational Site Number 208202
      • København Nv、丹麦、2400
        • Sanofi-Aventis Investigational Site Number 208201
      • Slagelse、丹麦、4200
        • Sanofi-Aventis Investigational Site Number 208205
  • 乌克兰
      • Chernivtsi、乌克兰、58022
        • Sanofi-Aventis Investigational Site Number 804203
      • Kiev、乌克兰、2091
        • Sanofi-Aventis Investigational Site Number 804201
      • Kyiv、乌克兰、31156
        • Sanofi-Aventis Investigational Site Number 804205
      • Kyiv、乌克兰
        • Sanofi-Aventis Investigational Site Number 804202
      • Vinnytsya、乌克兰、21010
        • Sanofi-Aventis Investigational Site Number 804204
  • 以色列
      • Haifa、以色列、31096
        • Sanofi-Aventis Investigational Site Number 376202
      • Holon、以色列、58100
        • Sanofi-Aventis Investigational Site Number 376201
      • Kfar Saba、以色列、44281
        • Sanofi-Aventis Investigational Site Number 376204
      • Tel Hashomer、以色列、52621
        • Sanofi-Aventis Investigational Site Number 376203
  • 俄罗斯联邦
      • Saratov、俄罗斯联邦、410030
        • Sanofi-Aventis Investigational Site Number 643203
      • St. Petersburg、俄罗斯联邦、194358
        • Sanofi-Aventis Investigational Site Number 643202
  • 加拿大
      • Brampton、加拿大、L6R 3J5
        • Sanofi-Aventis Investigational Site Number 124219
      • Chatham、加拿大、N7L 1C1
        • Sanofi-Aventis Investigational Site Number 124213
      • Chilliwack、加拿大、V2P 4M9
        • Sanofi-Aventis Investigational Site Number 124208
      • Etobicoke、加拿大、M9R 4E1
        • Sanofi-Aventis Investigational Site Number 124215
      • Quebec、加拿大、G1V 4G5
        • Sanofi-Aventis Investigational Site Number 124205
      • Red Deer、加拿大、T4N 6V7
        • Sanofi-Aventis Investigational Site Number 124202
      • Thornhill、加拿大、L4J 8L7
        • Sanofi-Aventis Investigational Site Number 124218
      • Toronto、加拿大、M4R 2G4
        • Sanofi-Aventis Investigational Site Number 124201
      • Toronto、加拿大、M9V 4B4
        • Sanofi-Aventis Investigational Site Number 124207
      • Victoria、加拿大、V8V 4A1
        • Sanofi-Aventis Investigational Site Number 124209
      • Winnipeg、加拿大、R3E 3P4
        • Sanofi-Aventis Investigational Site Number 124217
  • 匈牙利
      • Balatonfüred、匈牙利、8230
        • Sanofi-Aventis Investigational Site Number 348205
      • Budapest、匈牙利、1036
        • Sanofi-Aventis Investigational Site Number 348202
      • Budapest、匈牙利
        • Sanofi-Aventis Investigational Site Number 348207
      • Debrecen、匈牙利、4031
        • Sanofi-Aventis Investigational Site Number 348204
      • Gyula、匈牙利、5700
        • Sanofi-Aventis Investigational Site Number 348206
      • Szeged、匈牙利、6722
        • Sanofi-Aventis Investigational Site Number 348203
      • Zalaegerszeg、匈牙利、8900
        • Sanofi-Aventis Investigational Site Number 348201
  • 南非
      • Cape Town、南非、7708
        • Sanofi-Aventis Investigational Site Number 710202
      • Durban、南非、4092
        • Sanofi-Aventis Investigational Site Number 710201
      • Pretoria、南非
        • Sanofi-Aventis Investigational Site Number 710203
  • 印度
      • Ahmedabad、印度、380015
        • Sanofi-Aventis Investigational Site Number 356210
      • Bangalore、印度、560043
        • Sanofi-Aventis Investigational Site Number 356206
      • Bangalore、印度、560052
        • Sanofi-Aventis Investigational Site Number 356204
      • Bangalore、印度
        • Sanofi-Aventis Investigational Site Number 356202
      • Belgaum、印度、590001
        • Sanofi-Aventis Investigational Site Number 356201
      • Chennai、印度、600086
        • Sanofi-Aventis Investigational Site Number 356205
      • Indore、印度、452010
        • Sanofi-Aventis Investigational Site Number 356208
      • Karnal、印度、132001
        • Sanofi-Aventis Investigational Site Number 356203
      • Kochi、印度
        • Sanofi-Aventis Investigational Site Number 356207
      • Nagpur、印度、440012
        • Sanofi-Aventis Investigational Site Number 356209
  • 台湾
      • Changhua、台湾、500
        • Sanofi-Aventis Investigational Site Number 158204
      • Taichung、台湾、433
        • Sanofi-Aventis Investigational Site Number 158203
      • Taichung R.O.C.、台湾、407
        • Sanofi-Aventis Investigational Site Number 158201
      • Tainan Hsien、台湾、710
        • Sanofi-Aventis Investigational Site Number 158202
  • 哥伦比亚
      • Barranquilla、哥伦比亚
        • Sanofi-Aventis Investigational Site Number 170204
      • Bogota、哥伦比亚
        • Sanofi-Aventis Investigational Site Number 170201
      • Bogota、哥伦比亚
        • Sanofi-Aventis Investigational Site Number 170202
  • 墨西哥
      • Cuernavaca、墨西哥、62250
        • Sanofi-Aventis Investigational Site Number 484201
      • Durango、墨西哥、34270
        • Sanofi-Aventis Investigational Site Number 484204
      • Guadalajara、墨西哥、44600
        • Sanofi-Aventis Investigational Site Number 484203
      • México City、墨西哥、14050
        • Sanofi-Aventis Investigational Site Number 484206
      • Tlalnepantla、墨西哥、53160
        • Sanofi-Aventis Investigational Site Number 484205
  • 巴西
      • Belem、巴西、66073-000
        • Sanofi-Aventis Investigational Site Number 076207
      • Brasilia、巴西、71625-009
        • Sanofi-Aventis Investigational Site Number 076202
      • Porto Alegre、巴西、90035001
        • Sanofi-Aventis Investigational Site Number 076205
      • Sao Paulo、巴西、04024-002
        • Sanofi-Aventis Investigational Site Number 076204
  • 德国
      • Dresden、德国、01307
        • Sanofi-Aventis Investigational Site Number 276201
      • Mainz、德国、55116
        • Sanofi-Aventis Investigational Site Number 276202
      • St. Ingbert-Oberwürzbach、德国、66386
        • Sanofi-Aventis Investigational Site Number 276204
  • 意大利
      • Milano、意大利、20132
        • Sanofi-Aventis Investigational Site Number 380201
      • Perugia、意大利、61260
        • Sanofi-Aventis Investigational Site Number 380202
  • 捷克共和国
      • Hradec Kralove、捷克共和国、50005
        • Sanofi-Aventis Investigational Site Number 203202
      • Praha 5、捷克共和国、15006
        • Sanofi-Aventis Investigational Site Number 203204
  • 智利
      • Santiago、智利、7500010
        • Sanofi-Aventis Investigational Site Number 152202
      • Santiago、智利、7980378
        • Sanofi-Aventis Investigational Site Number 152203
      • Santiago、智利、8053095
        • Sanofi-Aventis Investigational Site Number 152206
      • Santiago、智利、8360156
        • Sanofi-Aventis Investigational Site Number 152204
      • Santiago、智利、8930211
        • Sanofi-Aventis Investigational Site Number 152205
      • Santiago、智利
        • Sanofi-Aventis Investigational Site Number 152201
  • 法国
      • Amiens Cedex 1、法国、80054
        • Sanofi-Aventis Investigational Site Number 250204
      • La Rochelle Cedex、法国、17019
        • Sanofi-Aventis Investigational Site Number 250206
      • Le Creusot、法国、71200
        • Sanofi-Aventis Investigational Site Number 250203
      • Nantes、法国、44093
        • Sanofi-Aventis Investigational Site Number 250201
      • Pierre Benite、法国、69310
        • Sanofi-Aventis Investigational Site Number 250202
  • 波兰
      • Krakow、波兰、31-548
        • Sanofi-Aventis Investigational Site Number 616202
      • Lubin、波兰、59-300
        • Sanofi-Aventis Investigational Site Number 616208
      • Plock、波兰、09-400
        • Sanofi-Aventis Investigational Site Number 616206
      • Pulawy、波兰、24-100
        • Sanofi-Aventis Investigational Site Number 616207
      • Sopot、波兰、81-756
        • Sanofi-Aventis Investigational Site Number 616205
      • Szczecin、波兰、70-506
        • Sanofi-Aventis Investigational Site Number 616201
      • Zabrze、波兰、41-8--
        • Sanofi-Aventis Investigational Site Number 616203
  • 波多黎各
      • Ponce、波多黎各、00717
        • Sanofi-Aventis Investigational Site Number 840226
      • San Juan、波多黎各、00917
        • Sanofi-Aventis Investigational Site Number 840216
  • 爱沙尼亚
      • Pärnu、爱沙尼亚、80018
        • Sanofi-Aventis Investigational Site Number 233201
      • Tallinn、爱沙尼亚、13415
        • Sanofi-Aventis Investigational Site Number 233203
      • Tartu、爱沙尼亚、50410
        • Sanofi-Aventis Investigational Site Number 233204
      • Viljandimaa、爱沙尼亚、71024
        • Sanofi-Aventis Investigational Site Number 233202
  • 瑞典
      • Göteborg、瑞典、413 45
        • Sanofi-Aventis Investigational Site Number 752204
      • Härnösand、瑞典、871 82
        • Sanofi-Aventis Investigational Site Number 752203
      • Luleå、瑞典、972 33
        • Sanofi-Aventis Investigational Site Number 752205
      • Malmö、瑞典、211 52
        • Sanofi-Aventis Investigational Site Number 752202
      • Stockholm、瑞典、111 57
        • Sanofi-Aventis Investigational Site Number 752201
  • 罗马尼亚
      • Brasov、罗马尼亚、500326
        • Sanofi-Aventis Investigational Site Number 642204
      • Bucharest、罗马尼亚、020725
        • Sanofi-Aventis Investigational Site Number 642208
      • Deva、罗马尼亚、330084
        • Sanofi-Aventis Investigational Site Number 642205
      • Iasi、罗马尼亚、700515
        • Sanofi-Aventis Investigational Site Number 642203
      • Oradea、罗马尼亚、410598
        • Sanofi-Aventis Investigational Site Number 642202
      • Targu Mures、罗马尼亚、540061
        • Sanofi-Aventis Investigational Site Number 642206
      • Timisoara、罗马尼亚、300456
        • Sanofi-Aventis Investigational Site Number 642207
      • Timisoara、罗马尼亚、300593
        • Sanofi-Aventis Investigational Site Number 642201
  • 美国
    • Arizona
      • Mesa、Arizona、美国、85206
        • Sanofi-Aventis Investigational Site Number 840223
    • Arkansas
      • Hot Springs、Arkansas、美国、71913
        • Sanofi-Aventis Investigational Site Number 840206
      • Little Rock、Arkansas、美国、72205
        • Sanofi-Aventis Investigational Site Number 840201
      • Mountain Home、Arkansas、美国、72653
        • Sanofi-Aventis Investigational Site Number 840212
    • California
      • Concord、California、美国、94520
        • Sanofi-Aventis Investigational Site Number 840215
      • Greenbrae、California、美国、94904
        • Sanofi-Aventis Investigational Site Number 840214
    • Florida
      • Orlando、Florida、美国、32835
        • Sanofi-Aventis Investigational Site Number 840221
    • Louisiana
      • Baton Rouge、Louisiana、美国、70808
        • Sanofi-Aventis Investigational Site Number 840211
    • Maryland
      • Hyattsville、Maryland、美国、20781
        • Sanofi-Aventis Investigational Site Number 840230
      • Rockville、Maryland、美国、20852
        • Sanofi-Aventis Investigational Site Number 840209
    • Michigan
      • Brighton、Michigan、美国、48114
        • Sanofi-Aventis Investigational Site Number 840219
    • New Jersey
      • Sea Girt、New Jersey、美国、08750
        • Sanofi-Aventis Investigational Site Number 840231
    • North Dakota
      • Fargo、North Dakota、美国、58103
        • Sanofi-Aventis Investigational Site Number 840208
    • Ohio
      • Mentor、Ohio、美国、44060
        • Sanofi-Aventis Investigational Site Number 840225
    • Oregon
      • Portland、Oregon、美国、97201-3098
        • Sanofi-Aventis Investigational Site Number 840222
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19146
        • Sanofi-Aventis Investigational Site Number 840202
    • Tennessee
      • Bristol、Tennessee、美国、37620
        • Sanofi-Aventis Investigational Site Number 840229
      • Germantown、Tennessee、美国、38138
        • Sanofi-Aventis Investigational Site Number 840205
    • Texas
      • Dallas、Texas、美国、75230
        • Sanofi-Aventis Investigational Site Number 840210
      • Houston、Texas、美国、77081
        • Sanofi-Aventis Investigational Site Number 840217
      • Houston、Texas、美国、77081
        • Sanofi-Aventis Investigational Site Number 840228
      • Plano、Texas、美国、75093
        • Sanofi-Aventis Investigational Site Number 840213
    • Virginia
      • Norfolk、Virginia、美国、23502
        • Sanofi-Aventis Investigational Site Number 840227
  • 荷兰
      • Amsterdam、荷兰、1066 EC
        • Sanofi-Aventis Investigational Site Number 528203
      • Groningen、荷兰、9728 NT
        • Sanofi-Aventis Investigational Site Number 528202
      • Zwijndrecht、荷兰、3331 LZ
        • Sanofi-Aventis Investigational Site Number 528204
  • 阿根廷
      • Buenos Aires、阿根廷
        • Sanofi-Aventis Investigational Site Number 032204
      • Capital Federal、阿根廷、1012
        • Sanofi-Aventis Investigational Site Number 032205
      • Capital Federal、阿根廷、1425
        • Sanofi-Aventis Investigational Site Number 032201
      • Capital Federal、阿根廷、C1056ABJ
        • Sanofi-Aventis Investigational Site Number 032209
      • Corrientes、阿根廷
        • Sanofi-Aventis Investigational Site Number 032211
      • Parana、阿根廷、(E3100BBJ)
        • Sanofi-Aventis Investigational Site Number 032202
      • Rosario、阿根廷、2000
        • Sanofi-Aventis Investigational Site Number 032203
  • 马来西亚
      • Kelantan、马来西亚、16150
        • Sanofi-Aventis Investigational Site Number 458203
      • Kuala Lumpur、马来西亚、56000
        • Sanofi-Aventis Investigational Site Number 458202

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria:

- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with insulin glargine and metformin

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
  • Metformin not at a stable dose of at least 1.5 gram per day for at least 3 months prior to the screening visit
  • Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea (SU) and TZDs (for example, alpha glucosidase inhibitor, other glucagon like peptide-1 [GLP-1] receptor agonists, dipeptidyl peptidase-IV [DPP-IV] inhibitors, insulin etc.) within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit
  • History of hypoglycemia unawareness
  • Body Mass Index (BMI) less than or equal to (<=) 20 kilogram per square meter (kg/m^2)
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion 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
  • 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 such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy 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 or diastolic blood pressure >180 millimeter of mercury (mmHg) or >110 mmHg, respectively
  • Laboratory findings at the time of screening: amylase and/or lipase, alanine aminotransferase >3 times upper limit of the normal (ULN) laboratory range; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, positive serum pregnancy test in females of childbearing potential; and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per milliliter [pmol/L])
  • 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 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, patient being investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol etc.)
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
  • Use of any investigational drug within 3 months prior to screening
  • Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
  • History of hypersensitivity to insulin glargine or to any of the excipients
  • 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
  • Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)
  • Allergic reaction to any GLP-1 receptor agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • Additional exclusion criteria during or at the end of the run-in phase before randomization: informed consent withdrawal (patient who was not willing to continue or failed to return), mean fasting SMPG calculated from the self-measurements for the 7 days prior to Visit 12 (Week -1) was >140 mg/dL (7.8 mmol/L) and HbA1c measured at Visit 12 (Week -1) is <7% or >9%, amylase and/or lipase > 3 times the ULN at Visit 12 (Week -1), patients with fasting plasma glucose (FPG) above the threshold value described for rescue (that is, FPG >240 mg/dL [13.3 mmol/L]), patients with any adverse event, which, by the judgment of the Investigator precludes the inclusion in the double-blind randomized treatment phase, and lack of compliance to protocol or to insulin glargine treatment during the run-in phase

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：利西拉来
Lixisenatide 的两步启动方案：10 微克 (mcg) 每天一次 (QD) 持续 1 周，然后是 15 微克 QD 持续 1 周，然后 20 微克 QD 直至第 24 周。
药品：利西拉来 (AVE0010)
每天早餐前一小时内通过皮下注射自我给药一次。
药品：二甲双胍
二甲双胍以稳定剂量（每天至少 1.5 克）持续服用至第 24 周。
药品：Insulin glargine
Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.
其他名称：
  • 来得时®
设备：Pen auto-injector
Lantus® SoloStar® OptiClik®
药品：Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.
安慰剂比较：安慰剂
容量匹配安慰剂的两步启动方案：10 微克 QD 持续 1 周，随后 15 微克 QD 持续 1 周，然后 20 微克 QD 直至第 24 周。
药品：安慰剂
每天早餐前一小时内通过皮下注射自我给药一次。
药品：二甲双胍
二甲双胍以稳定剂量（每天至少 1.5 克）持续服用至第 24 周。
药品：Insulin glargine
Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.
其他名称：
  • 来得时®
设备：Pen auto-injector
Lantus® SoloStar® OptiClik®
药品：Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
大体时间：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 14 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 assessment for at least 1 efficacy variable, were required.
Baseline, Week 24

次要结果测量

结果测量
措施说明
大体时间
第 24 周时体重相对于基线的变化
大体时间：基线，第 24 周
通过从第 24 周的值中减去基线值来计算变化。 该疗效变量的治疗期间是从第一次研究药物给药到最后一次研究药物给药后 3 天或开始救援治疗的时间，以最早者为准。 对于要包括在 mITT 人群中的患者，需要对至少 1 个功效变量进行基线和至少 1 次基线后评估。
基线，第 24 周
第 24 周时平均 7 点自我监测血浆葡萄糖 (SMPG) 曲线相对于基线的变化
大体时间：基线，第 24 周
患者每周一次记录每餐前和餐后 2 小时以及睡前测量的 7 点血浆葡萄糖谱，并计算 7 个时间点的平均值。 该疗效变量的治疗期间是从研究药物的第一次给药到研究药物的最后给药日或到引入挽救治疗的时间，以最早者为准。 对于要包括在 mITT 人群中的患者，需要对至少 1 个功效变量进行基线和至少 1 次基线后评估。
基线，第 24 周
第 24 周空腹血糖 (FPG) 相对于基线的变化
大体时间：基线，第 24 周
通过从第 24 周的值中减去基线值来计算变化。 该疗效变量的治疗期间是从第一次研究药物给药到最后一次研究药物给药后 1 天的时间，或直到引入挽救治疗的时间，以最早者为准。 对于要包括在 mITT 人群中的患者，需要对至少 1 个功效变量进行基线和至少 1 次基线后评估。
基线，第 24 周
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
大体时间：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. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
Change From Baseline in Glucose Excursion at Week 24
大体时间：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. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
Change From Baseline in Average Insulin Glargine Daily Dose at Week 24
大体时间：Baseline, Week 24
Change was calculated by subtracting the 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. For a patient to be included in mITT population, both baseline and at least 1 post baseline 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
大体时间：Week 24
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 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 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
大体时间：Week 24
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 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 assessment for at least 1 efficacy variable, were required.
Week 24
Percentage of Patients Requiring Rescue Therapy During the Double-blind Period
大体时间：Baseline up to Week 24
Routine fasting SMPG, central laboratory FPG and HbA1c 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 were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Baseline up to Week 24
Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24
大体时间：Baseline, Week 24
Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. 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 assessment for at least 1 efficacy variable, were required.
Baseline, Week 24

其他结果措施

结果测量
措施说明
大体时间
有症状性低血糖和严重症状性低血糖的患者人数
大体时间：在最后一次给药后 3 天内首次服用研究药物
症状性低血糖是一种具有临床症状的事件，被认为是由伴随血浆葡萄糖低于 60 mg/dL (3.3 mmol/L) 的低血糖发作引起的，或者与口服碳水化合物、静脉注射葡萄糖或胰高血糖素后迅速恢复相关，如果没有可用的血浆葡萄糖测量值。 严重症状性低血糖是症状性低血糖事件，其中患者需要他人的帮助，并且与血浆葡萄糖水平低于 36 mg/dL (2.0 mmol/L) 或口服碳水化合物、静脉注射葡萄糖或胰高血糖素后迅速恢复有关, 如果没有血浆葡萄糖测量可用。
在最后一次给药后 3 天内首次服用研究药物
第 24 周体重较基线至少减轻 5% 的患者百分比
大体时间：基线，第 24 周
该疗效变量的治疗期间是从第一次研究药物给药到最后一次研究药物给药后 3 天或开始救援治疗的时间，以最早者为准。 对于要包括在 mITT 人群中的患者，需要对至少 1 个功效变量进行基线和至少 1 次基线后评估。
基线，第 24 周

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Sanofi

调查人员

  • 研究主任：Clinical Study Operations、Sanofi

出版物和有用的链接

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年10月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2009年9月10日

首先提交符合 QC 标准的

2009年9月10日

首次发布 (估计)

2009年9月11日

研究记录更新

最后更新发布 (估计)

2016年10月11日

上次提交的符合 QC 标准的更新

2016年8月18日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • EFC10781
  • EudraCT : 2008-007335-40

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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