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

18 de agosto de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

446

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lixisenatida
Régimen de inicio de 2 pasos de lixisenatida: 10 microgramos (mcg) una vez al día (QD) durante 1 semana, seguido de 15 mcg QD durante 1 semana, luego 20 mcg QD hasta la semana 24.
Droga: Lixisenatida (AVE0010)
Autoadministrado mediante inyecciones subcutáneas una vez al día dentro de la hora anterior al desayuno.
Droga: Metformina
La metformina debe continuarse a una dosis estable (al menos 1,5 gramos por día) hasta la semana 24.
Droga: 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.
Otros nombres:
  • Lantus®
Dispositivo: Pen auto-injector
Lantus® SoloStar® OptiClik®
Droga: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.
Comparador de placebos: Placebo
Régimen de inicio de 2 pasos de placebo equivalente al volumen: 10 mcg QD durante 1 semana, seguido de 15 mcg QD durante 1 semana, luego 20 mcg QD hasta la semana 24.
Droga: Placebo
Autoadministrado mediante inyecciones subcutáneas una vez al día dentro de la hora anterior al desayuno.
Droga: Metformina
La metformina debe continuarse a una dosis estable (al menos 1,5 gramos por día) hasta la semana 24.
Droga: 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.
Otros nombres:
  • Lantus®
Dispositivo: Pen auto-injector
Lantus® SoloStar® OptiClik®
Droga: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el inicio en el peso corporal en la semana 24
Periodo de tiempo: Línea de base, semana 24
El cambio se calculó restando el valor inicial del valor de la semana 24. El período de tratamiento para esta variable de eficacia es el tiempo desde la primera dosis del fármaco del estudio hasta 3 días después de la última dosis del fármaco del estudio o hasta la introducción de la terapia de rescate, lo que ocurra primero. Para incluir a un paciente en la población mITT, se requería una evaluación tanto inicial como posterior a la inicial para al menos 1 variable de eficacia.
Línea de base, semana 24
Cambio desde el inicio en el perfil promedio de glucosa plasmática autocontrolada (SMPG) de 7 puntos en la semana 24
Periodo de tiempo: Línea de base, semana 24
Los pacientes registraron un perfil de glucosa en plasma de 7 puntos medido antes y 2 horas después de cada comida y al acostarse una vez por semana y se calculó el valor promedio para los 7 puntos de tiempo. El período de tratamiento para esta variable de eficacia es el tiempo desde la primera dosis del fármaco del estudio hasta el último día de dosificación del fármaco del estudio o hasta la introducción de la terapia de rescate, lo que ocurra primero. Para incluir a un paciente en la población mITT, se requería una evaluación tanto inicial como posterior a la inicial para al menos 1 variable de eficacia.
Línea de base, semana 24
Cambio desde el inicio en la glucosa plasmática en ayunas (FPG) en la semana 24
Periodo de tiempo: Línea de base, semana 24
El cambio se calculó restando el valor inicial del valor de la semana 24. El período de tratamiento para esta variable de eficacia es el tiempo desde la primera dosis del fármaco del estudio hasta 1 día después de la última dosis del fármaco del estudio o hasta la introducción de la terapia de rescate, lo que ocurra primero. Para incluir a un paciente en la población mITT, se requería una evaluación tanto inicial como posterior a la inicial para al menos 1 variable de eficacia.
Línea de base, semana 24
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Número de pacientes con hipoglucemia sintomática e hipoglucemia sintomática grave
Periodo de tiempo: Primera dosis del fármaco del estudio hasta 3 días después de la administración de la última dosis
La hipoglucemia sintomática fue un evento con síntomas clínicos que se consideró que eran el resultado de un episodio hipoglucémico con una glucosa plasmática concomitante inferior a 60 mg/dl (3,3 mmol/l) o asociado con una pronta recuperación después de la administración oral de carbohidratos, glucosa intravenosa o glucagón si no se disponía de medición de glucosa en plasma. La hipoglucemia sintomática grave fue un evento de hipoglucemia sintomática en el que el paciente requirió la asistencia de otra persona y se asoció con un nivel de glucosa en plasma por debajo de 36 mg/dL (2,0 mmol/L) o una pronta recuperación después de la administración oral de carbohidratos, glucosa intravenosa o glucagón. , si no se disponía de una medición de glucosa en plasma.
Primera dosis del fármaco del estudio hasta 3 días después de la administración de la última dosis
Porcentaje de pacientes con al menos un 5 % de pérdida de peso desde el inicio en la semana 24
Periodo de tiempo: Línea de base, semana 24
El período de tratamiento para esta variable de eficacia es el tiempo desde la primera dosis del fármaco del estudio hasta 3 días después de la última dosis del fármaco del estudio o hasta la introducción de la terapia de rescate, lo que ocurra primero. Para incluir a un paciente en la población mITT, se requería una evaluación tanto inicial como posterior a la inicial para al menos 1 variable de eficacia.
Línea de base, semana 24

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Investigadores

  • Director de estudio: Clinical Study Operations, Sanofi

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2009

Finalización primaria (Actual)

1 de agosto de 2011

Finalización del estudio (Actual)

1 de agosto de 2011

Fechas de registro del estudio

Enviado por primera vez

10 de septiembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

10 de septiembre de 2009

Publicado por primera vez (Estimar)

11 de septiembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de octubre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

18 de agosto de 2016

Última verificación

1 de agosto de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EFC10781
  • EudraCT : 2008-007335-40

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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